D C54450 CDRH Health Effect - Clinical Code Terminology C50450 Acanthamoeba Keratitis Keratitis due to infection by acanthamoeba; it is usually associated with soft contact lens wear, particularly overnight wear. Acanthamoeba Keratitis 1945 Keratitis due to infection by acanthamoeba. IMDRF:E082901 D C54450 CDRH Health Effect - Clinical Code Terminology C50658 Muscle Weakness A reduction in the strength of one or more muscles. Muscle Weakness 1967 A reduction in the strength of one or more muscles. IMDRF:E1621 A C54450 CDRH Health Effect - Clinical Code Terminology C187271 Muscle Weakness/Atrophy A reduction in the strength and/or mass of one or more muscles. Muscle Weakness/Atrophy 1967 A reduction in the strength and/or mass of one or more muscles. IMDRF:E1621 A C54451 CDRH Medical Device Problem Code Terminology C187247 Lack of Effect Problems associated with a product having less efficacy than expected. No other malfunctions could be identified. Lack of Effect 4065 Problems associated with a product having less efficacy than expected. No other malfunctions could be identified. IMDRF:A0105 A C54451 CDRH Medical Device Problem Code Terminology C187248 Device Stenosis Problem associated with the narrowing or obstruction of the device (e.g. prosthetic heart valves, stents, etc.). Device Stenosis 4066 Problem associated with the narrowing or obstruction of the device (e.g. prosthetic heart valves, stents, etc.). IMDRF:A0106 A C54451 CDRH Medical Device Problem Code Terminology C187249 Extra Component More than the usual number of components present/additional components from this or other devices. Extra Components 4067 More than the usual number of components present/additional components from this or other devices. IMDRF:A020603 A C54451 CDRH Medical Device Problem Code Terminology C187251 Central Regurgitation Heart Valve Problem associated with the escape of blood through the center of the heart valve or the backward flow of blood through the heart valve. Central Regurgitation 4068 Problem associated with the escape of blood through the center of the heart valve or the backward flow of blood through the heart valve. IMDRF:A050406 A C54451 CDRH Medical Device Problem Code Terminology C187252 Powder Leak Escape (release, discharge) of powder (including particulates) through an unintended location, often accompanied by a loss of pressure and/or output. Powder Leak 4069 Escape (release, discharge) of powder (including particulates) through an unintended location, often accompanied by a loss of pressure and/or output. IMDRF:A050407 A C54451 CDRH Medical Device Problem Code Terminology C187253 Failure to Seal Problem associated with the device failing to seal the intended vessel with the device intended to provide a seal (e.g. electrosurgical hemostasis). Failure to Seal 4070 Problem associated with the device failing to seal the intended vessel with the device intended to provide a seal (e.g. electrosurgical hemostasis). IMDRF:A050705 A C54451 CDRH Medical Device Problem Code Terminology C187254 Adhesive Too Strong Strength of an adhesive bond is too great; typically used when the adhesive is meant as a temporary hold but is acting in a more permanent manner. Adhesive Too Strong 4071 Strength of an adhesive bond is too great; typically used when the adhesive is meant as a temporary hold but is acting in a more permanent manner. IMDRF:A050901 A C54451 CDRH Medical Device Problem Code Terminology C187257 Poor Visibility Implanted device is difficult to detect on imaging modalities, e.g. insufficient visibility. Poor Visibility 4072 Implanted device is difficult to detect on imaging modalities, e.g. insufficient visibility. IMDRF:A090814 A C54451 CDRH Medical Device Problem Code Terminology C187259 Wrong Label Problem associated with an incorrect label being affixed to the device or packaging. Wrong Label 4073 Problem associated with an incorrect label being affixed to the device or packaging. IMDRF:A210106 A C91800 CDRH Cause Investigation - Type of Investigation Terminology C187262 Event History Log Review The investigation involved the analysis of the history log files retrieved from the device to support possible causes for the adverse event. Event History Log Review 4121 The investigation involved the analysis of the history log files retrieved from the device to support possible causes for the adverse event. IMDRF:B24 A C91801 CDRH Cause Investigation - Investigation Findings Terminology C187263 Artificial Intelligence Training/Validation Problem Identified Problem associated with the training and/or validation of artificial intelligence, including machine learning algorithms. Artificial Intelligence Training/Validation Problem Identified 4249 Problem associated with the training and/or validation of artificial intelligence, including machine learning algorithms. IMDRF:C1010 A C91801 CDRH Cause Investigation - Investigation Findings Terminology C187264 Corrupt Software The device software becomes corrupted and results in device malfunction. Corrupt Software 4250 The device software becomes corrupted and results in device malfunction. IMDRF:C1011 A C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C187265 Reasonably Foreseeable Misuse Problems related to the use of a device in a way not intended in the instructions for use, but which may result from readily predictable human behavior. Reasonably Foreseeable Misuse 4319 Problems related to the use of a device in a way not intended in the instructions for use, but which may result from readily predictable human behavior. IMDRF:D1108 A C91802 CDRH Cause Investigation - Investigation Conclusion Terminology C187266 Cause Traced to Artificial Intelligence Training/Validation Process Problem traced to the process or dataset(s) used for training and/or validating artificial intelligence, including machine learning algorithms. Cause Traced to Artificial Intelligence Training/Validation Process 4320 Problem traced to the process or dataset(s) used for training and/or validating artificial intelligence, including machine learning algorithms. IMDRF:D19 A C54450 CDRH Health Effect - Clinical Code Terminology C84501 Restless Leg Syndrome A condition that occurs while resting or lying in bed; it is characterized by an irresistible urgency to move the legs to obtain relief from a strange and uncomfortable sensation in the legs. Restless Legs Syndrome 4584 A condition that is characterized by an irresistible urgency to move the legs to obtain relief from a strange and uncomfortable sensation in the legs. IMDRF:E012208 A C54450 CDRH Health Effect - Clinical Code Terminology C26769 Cranial Nerve VII Palsy Partial or complete paralysis of the facial muscles of one side of a person's face. It is caused by damage to the seventh cranial nerve. It is usually temporary but it may recur. Facial Paralysis 4585 A partial or complete loss of function of one or more of the facial muscles resulting in paralysis of the facial regions. Includes both central and peripheral facial paralysis or palsy. IMDRF:E012209 A C54450 CDRH Health Effect - Clinical Code Terminology C187268 Increased Intracranial Pressure Pressure within the craniospinal compartment is increased. Increased Intracranial Pressure 4586 Pressure within the craniospinal compartment is increased. IMDRF:E0140 A C54450 CDRH Health Effect - Clinical Code Terminology C127829 Pneumocephalus The presence of air or gas within the cranial cavity. Pneumocephalus 4587 The presence of air or gas within the cranial cavity. IMDRF:E0141 A C54450 CDRH Health Effect - Clinical Code Terminology C85035 Pseudotumor Cerebri An idiopathic disorder characterized by chronic increase in the intracranial pressure. It occurs predominantly in obese females of childbearing age. It is associated with papilledema. Idiopathic Intracranial Hypertension 4588 A condition that mimics the presence of a tumour (Pseudotumour Cerebri) or hydrocephalus, caused by chronic increase in intracranial pressure. IMDRF:E0142 A C54450 CDRH Health Effect - Clinical Code Terminology C121627 Altered Level of Consciousness A level of awareness and arousal other than normal. Altered State of Consciousness 4589 A level of awareness and arousal other than normal. IMDRF:E0143 A C54450 CDRH Health Effect - Clinical Code Terminology C187270 Increased Level of Consciousness A neurological state characterized by increased ability to perceive and respond. Increased Level of Consciousness 4590 A neurological state characterised by increased ability to perceive and respond. IMDRF:E014301 A C54450 CDRH Health Effect - Clinical Code Terminology C78253 Depressed Level Of Consciousness A neurologic state characterized by decreased ability to perceive and respond. Decreased Level of Consciousness 4591 A neurological state characterised by decreased ability to perceive and respond. IMDRF:E014302 A C54450 CDRH Health Effect - Clinical Code Terminology C2981 Delirium A usually reversible condition characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation, and hallucinations. Causes include drug abuse, poisoning, infectious processes, and fluid and electrolyte imbalance. Delirium 4592 A usually reversible condition characterized by the acute and sudden development of confusion, illusions, movement changes, inattentiveness, agitation and hallucinations. IMDRF:E0207 A C54450 CDRH Health Effect - Clinical Code Terminology C78576 Psychosis A mental disorder characterized by personality change, impaired functioning, and loss of touch with reality. Psychosis 4593 A mental disorder characterized by personality change, impaired functioning and loss of touch with reality. IMDRF:E0208 A C54450 CDRH Health Effect - Clinical Code Terminology C35524 Leukocytosis A laboratory test result indicating an increased number of white blood cells in the peripheral blood. High White Blood Cell Count 4594 The white blood cell count is above the normal range. IMDRF:E0311 A C54450 CDRH Health Effect - Clinical Code Terminology C187274 Transfusion Reaction Adverse events associated with the transfusion of whole blood or one of its components, most commonly a hemolytic reaction to cross-typed blood. Transfusion Reaction 4596 Adverse events associated with the transfusion of whole blood or one of its components, most commonly a hemolytic reaction to cross-typed blood. IMDRF:E0312 A C54450 CDRH Health Effect - Clinical Code Terminology C187275 Abnormal Blood Protein One or more of the blood protein levels being higher or lower than normal (e.g. Albumin, C-reactive Protein). Abnormal Blood Protein 4595 One or more of the blood protein levels being higher or lower than normal (e.g. Albumin, C-reactive Protein). IMDRF:E0313 A C54450 CDRH Health Effect - Clinical Code Terminology C187286 Eye Irritation A generic term used to describe sensations that bother the eyes like dryness, itchiness, burning and grittiness. Eye Irritation 4803 A generic term used to describe sensations that bother the eyes like dryness, itchiness, burning and grittiness. IMDRF:E0485 A C54450 CDRH Health Effect - Clinical Code Terminology C187276 Expanding Aneurysm Expansion of aneurysm. Aneurysm Expansion 4597 Expansion of aneurysm. IMDRF:E050102 A C54450 CDRH Health Effect - Clinical Code Terminology C187278 Reduced Blood Flow Inadequate blood flow. Reduced Blood Flow 4598 Inadequate blood flow to a particular area of the body. IMDRF:E0519 A C54450 CDRH Health Effect - Clinical Code Terminology C187283 Upper Respiratory Tract Injury Mechanical or chemical injuries to the upper airways, including trachea, pharynx and larynx. Upper Respiratory Tract Injury 4599 Mechanical or chemical injuries to the upper airways, including trachea, pharynx and larynx. IMDRF:E0753 A C54450 CDRH Health Effect - Clinical Code Terminology C118749 Infectious Keratitis Inflammation of the cornea secondary to an infectious process. Infective Keratitis 1945 Keratitis due to infection, including infection by acanthamoeba. IMDRF:E082901 A C54450 CDRH Health Effect - Clinical Code Terminology C28210 Photophobia Increased sensitivity of the eyes to light, which can result in the avoidance of light exposure. Photophobia 4801 Increased sensitivity of the eyes to light causing discomfort or pain. IMDRF:E083804 A C54450 CDRH Health Effect - Clinical Code Terminology C37941 Diplopia The condition in which a single object appears as two objects. Also called "double vision." (from medterms.com) Diplopia/Double Vision 4802 Perception of multiple images from one object. IMDRF:E083903 A C54450 CDRH Health Effect - Clinical Code Terminology C187287 Corneal Thinning Progressive deformation of the corneal structure, characterized by thinning of the cornea. Corneal Thinning 4804 Progressive deformation of the corneal structure, characterized by thinning of the cornea. IMDRF:E0846 A C54450 CDRH Health Effect - Clinical Code Terminology C187288 Pigment Dispersion Syndrome Condition where iris pigment is released into the anterior chamber and deposited in the trabecular meshwork, due to a procedure or device implantation. Pigment Dispersion Syndrome 4805 Condition where iris pigment is released into the anterior chamber and deposited in the trabecular meshwork, due to a procedure or device implantation. IMDRF:E0847 A C54450 CDRH Health Effect - Clinical Code Terminology C187360 Corneal Endothelial Cell Loss A decrease in corneal endothelial cell density. Corneal Endothelial Cell Loss 4806 Decrease in corneal endothelial cell density. IMDRF:E0848 A C54450 CDRH Health Effect - Clinical Code Terminology C187361 Posterior Capsule Opacification Remnant lens epithelial cell proliferation and migration to the posterior capsule. Posterior Capsule Opacification 4807 Remnant lens epithelial cell proliferation and migration to the posterior capsule. IMDRF:E0849 A C54450 CDRH Health Effect - Clinical Code Terminology C26728 Conjunctival Hemorrhage A hemorrhage occurring in the conjunctiva of the eye. Conjunctival Hemorrhage 4808 Blood extravasation in the conjunctiva. IMDRF:E0850 A C54450 CDRH Health Effect - Clinical Code Terminology C187279 Retinal Hemorrhage Blood extravasation in the retina. Retinal Hemorrhage 4809 Blood extravasation in the retina. IMDRF:E0851 A C54450 CDRH Health Effect - Clinical Code Terminology C187280 Choroidal Hemorrhage Blood extravasation in the choroid. Choroidal Hemorrhage 4810 Blood extravasation in the choroid. IMDRF:E0852 A C54450 CDRH Health Effect - Clinical Code Terminology C187281 Optic Nerve Sheath Hemorrhage Blood extravasation in the optic nerve sheath. Optic Nerve Sheath Hemorrhage 4811 Blood extravasation in the Optic Nerve Sheath. IMDRF:E0853 A C54450 CDRH Health Effect - Clinical Code Terminology C37944 Ear Pain Painful sensation in the ear region. Ear Pain 4812 Earache or ear pain. IMDRF:E0907 A C54450 CDRH Health Effect - Clinical Code Terminology C27193 Ear Infection A viral or bacterial infection that affects the external, middle, or inner ear. It may follow an upper respiratory infection. Signs and symptoms include pain, ear discharge, ear fullness, hearing loss, vertigo, nausea, and vomiting. Ear Infection 4813 Infection of the ear. IMDRF:E0908 A C54450 CDRH Health Effect - Clinical Code Terminology C3299 Infectious Otitis Externa Inflammation of the anatomical structures of the outer ear and ear canal secondary to an infectious process. Bacterial etiology is most common, but fungal infection is also possible. Symptoms include erythema, edema, and pain. Otitis Externa 4814 An infectious process involving the outer ear and ear canal. IMDRF:E090801 A C54450 CDRH Health Effect - Clinical Code Terminology C34885 Otitis Media Inflammation of the anatomical structures of the middle ear, which is most often caused by an infectious process. Symptoms include erythema and edema of the tympanic membrane, pain, and possibly fever. Middle Ear Inflammation 4816 Inflammation (swelling and redness) to the middle ear. IMDRF:E0909 A C54450 CDRH Health Effect - Clinical Code Terminology C128369 Labyrinthitis Inflammation of the anatomical structures of the inner ear secondary to an infectious process. Symptoms include severe vertigo, nausea, vomiting, anxiety, and pain. Viral etiology is most common, and recent history of an upper respiratory infection is common. Labyrinthitis 4817 An inflammation of the labyrinth in the inner ear that causes dizziness and reduced or distorted hearing. IMDRF:E0910 A C54450 CDRH Health Effect - Clinical Code Terminology C187363 Fecal Urgency A continual or recurrent inclination to evacuate the bowels. Fecal Urgency 4818 A continual or recurrent inclination to evacuate the bowels. IMDRF:E1034 A C54450 CDRH Health Effect - Clinical Code Terminology C99012 Pneumoperitoneum Free air within the peritoneal cavity. Pneumoperitoneum 4819 Free air within the peritoneal cavity. IMDRF:E1035 A C54450 CDRH Health Effect - Clinical Code Terminology C187364 Biliary Leak Sudden unexpected leakage of bile from the liver or soft tissue. Biliary Leak 4820 Sudden unexpected leakage of bile from the liver or soft tissue. IMDRF:E1108 A C54450 CDRH Health Effect - Clinical Code Terminology C26718 Cholangitis An acute or chronic inflammatory process affecting the biliary tract. Cholangitis 4821 Inflammation of the bile duct. IMDRF:E1109 A C54450 CDRH Health Effect - Clinical Code Terminology C3112 Hypercalcemia Abnormally high concentration of calcium in the peripheral blood. Hypercalcemia 4822 Higher than normal levels of calcium in the circulating blood. IMDRF:E120203 A C54450 CDRH Health Effect - Clinical Code Terminology C37973 Hypocalcemia Lower than normal levels of calcium in the circulating blood. Hypocalcemia 4823 Lower than normal levels of calcium in the circulating blood. IMDRF:E120204 A C54450 CDRH Health Effect - Clinical Code Terminology C37968 Hyperkalemia Higher than normal levels of potassium in the circulating blood; associated with kidney failure or sometimes with the use of diuretic drugs. Hyperkalemia 4824 Higher than normal levels of potassium in the circulating blood. IMDRF:E120205 A C54450 CDRH Health Effect - Clinical Code Terminology C37974 Hypokalemia Lower than normal levels of potassium in the circulating blood. Hypokalemia 4825 Lower than normal levels of potassium in the circulating blood. IMDRF:E120206 A C54450 CDRH Health Effect - Clinical Code Terminology C187367 Blood Bicarbonate Increased Higher than normal levels of bicarbonate in the blood. Blood Bicarbonate Increased 4826 Higher than normal levels of bicarbonate in the blood. IMDRF:E120207 A C54450 CDRH Health Effect - Clinical Code Terminology C78181 Serum Bicarbonate Decreased A laboratory test result which indicates decreased levels of bicarbonate in the serum. Blood Bicarbonate Decreased 4827 Lower than normal levels of bicarbonate in the blood. IMDRF:E120208 A C54450 CDRH Health Effect - Clinical Code Terminology C113750 Hyperphosphatemia Abnormally high level of phosphate in the blood. Hyperphosphatemia 4828 Higher than normal levels of phosphate in the circulating blood. IMDRF:E120209 A C54450 CDRH Health Effect - Clinical Code Terminology C187366 Breast Feeding Problem Issues related to the ability to breastfeed. Breast Feeding Problem 4829 Issues related to the ability to breastfeed. IMDRF:E1418 A C54450 CDRH Health Effect - Clinical Code Terminology C3836 Infertility Inability to conceive for at least one year after trying and having unprotected sex. Causes of female infertility include endometriosis, fallopian tubes obstruction, and polycystic ovary syndrome. Causes of male infertility include abnormal sperm production or function, blockage of the epididymis, blockage of the ejaculatory ducts, hypospadias, exposure to pesticides, and health related issues. Infertility 4830 Inability to conceive for at least one year after trying and having unprotected sex. Causes of female infertility include endometriosis, fallopian tubes obstruction, and polycystic ovary syndrome. Causes of male infertility include abnormal sperm production or function, blockage of the epididymis, blockage of the ejaculatory ducts and hypospadias. IMDRF:E1520 A C54450 CDRH Health Effect - Clinical Code Terminology C110937 Musculoskeletal Finding Symptoms, physical examination results, and/or laboratory rest results related to the muscles and bones. Unspecified Musculoskeletal problem 4535 The report describes a non-specific problem with the musculoskeletal system. Note: Please use "Appropriate Term / Code Not Available" if the report describes a specific problem but the relevant term does not exist. IMDRF:E1635 A C54450 CDRH Health Effect - Clinical Code Terminology C187368 Tooth Loss One or more teeth lost/dislodged from the mouth. Tooth Loss 4831 One or more teeth lost/dislodged from the mouth. IMDRF:E1636 A C54450 CDRH Health Effect - Clinical Code Terminology C94407 Bursitis Painful inflammation of the bursa. It most often affects the hips, shoulders, and elbows. Bursitis 4832 Inflammation of the fluid-filled pad (bursa). IMDRF:E1637 A C54450 CDRH Health Effect - Clinical Code Terminology C35606 Cartilage Injury Trauma to cartilage. Cartilage damage 4833 Damage of cartilage. IMDRF:E1638 A C54450 CDRH Health Effect - Clinical Code Terminology C187369 Joint Impingement A painful condition caused by the friction of joint tissues. Joint Impingement 4834 Impingement relating to joints. Can be e.g. implant-on-bone, implant-on-soft tissue, or implant-on-implant impingement. IMDRF:E1639 A C54450 CDRH Health Effect - Clinical Code Terminology C128368 Mastoiditis Inflammation of the mucosal lining of the mastoid antrum and mastoid air cell system of the mastoid process. Mastoiditis 4835 An infection of the bony air cells in the mastoid bone. IMDRF:E1640 A C54450 CDRH Health Effect - Clinical Code Terminology C26901 Erythema Red discoloration of the skin caused by infectious agents, inflammation, drug hypersensitivity, or underlying disease. Erythema 1840 Red discoloration of the skin. IMDRF:E171601 A C54450 CDRH Health Effect - Clinical Code Terminology C79731 Skin Hyperpigmentation Darkening of the skin due to excessive melanin deposition. Causes include skin injuries, pregnancy, eczema, and Addison disease. Hyperpigmentation 4837 Darkening of the skin due to excessive melanin deposition. IMDRF:E171602 A C54450 CDRH Health Effect - Clinical Code Terminology C50435 Skin Wrinkling A fold, ridge or crease of the skin. Wrinkling 2613 A folding, ridge or creasing of the skin. IMDRF:E1723 A C54450 CDRH Health Effect - Clinical Code Terminology C74592 Dry Skin The pores are generally fine with a papery thin texture that feels dry to the touch. Usually flaky and dull looking. Dry Skin 4839 Skin that has become dry in texture and flaky. IMDRF:E1724 A C54450 CDRH Health Effect - Clinical Code Terminology C187371 Injection Site Pooling Liquid or a pocket of air trapped under the skin, typically due to injection procedures. Injection Site Pooling 4840 Liquid or a pocket of air trapped under the skin, typically due to injection problems. Does not include inflammation. IMDRF:E1725 A C54450 CDRH Health Effect - Clinical Code Terminology C9292 Solid Neoplasm A benign or malignant neoplasm arising from tissues that do not include fluid areas. Representative examples include epithelial neoplasms (e.g. lung carcinoma, prostate carcinoma, breast carcinoma, colon carcinoma), and neoplasms arising from the soft tissues and bones (e.g. leiomyosarcoma, liposarcoma, chondrosarcoma, osteosarcoma). Neoplasms originating from the blood or bone marrow (leukemias and myeloproliferative disorders) are not considered solid tumors. Solid Tumour 4552 Abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancerous), or malignant (cancerous). Different types of solid tumours are named for the type of cells that form them. If tumours are associated with those under the term cancer, these terms should be used. IMDRF:E1804 A C54450 CDRH Health Effect - Clinical Code Terminology C177438 Bone Cement Implantation Syndrome A rare and potentially fatal perioperative complication of cemented bone surgery, characterized by hypotension, hypoxia, cardiac dysrhythmias, and in severe cases cardiac arrest. Bone Cement Implantation Syndrome 4583 A rare and potentially fatal perioperative complication of cemented bone surgery, characterised by hypotension, hypoxia, cardiac dysrhythmias, and in severe cases cardiac arrest. IMDRF:E2120 A C54450 CDRH Health Effect - Clinical Code Terminology C187282 Endoleak Persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure. Endoleaks 4843 Persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure. IMDRF:E2121 A C54450 CDRH Health Effect - Clinical Code Terminology C35024 Sinusitis An acute or chronic inflammatory process affecting the mucous membranes of any sinus cavity. Sinusitis 4844 Inflammation (swelling and redness) of the paranasal sinuses, associated or related to implantation procedures or devices. IMDRF:E2122 A C54450 CDRH Health Effect - Clinical Code Terminology C161592 Elevated LDH An indication that the concentration of lactate dehydrogenase found in a sample is higher than previous noted or above the normal range. Lactate Dehydrogenase Increased 4567 A laboratory test result indicating an increase in the lactate dehydrogenase concentration of a biological sample. IMDRF:E2204 A C54450 CDRH Health Effect - Clinical Code Terminology C102993 Bacteremia A laboratory test result that indicates the presence of bacteria in the blood. Bacteremia 4846 Condition that relates to the presence of viable bacteria in the bloodstream, whether associated with active disease or not. IMDRF:E2205 A C54450 CDRH Health Effect - Clinical Code Terminology C187380 High Metal Ion Levels High blood or serum levels of ions which are attributed to one or more medical devices used, such as but not limited to Co, Cr, Ti, Ni, Mo. High metal ion levels 4847 High blood or serum levels of ions which are attributed to one or more medical devices used, such as but not limited to Co, Cr, Ti, Ni, Mo. IMDRF:E2206 A C54450 CDRH Health Effect - Clinical Code Terminology C78262 Edema Limbs Swelling due to an excessive accumulation of fluid in the upper or lower extremities. Peripheral Edema 4578 accumulation of fluid in tissues perfused by the peripheral vascular system. IMDRF:E233801 A C171094 CDRH Health Effect - Impact Code Terminology C50862 Radiation Overdose A higher than intended cumulative dose of radiation to a single field. Radiation Overdose 1510 A higher than intended cumulative dose of radiation to a single field. IMDRF:F100501 A C171094 CDRH Health Effect - Impact Code Terminology C187376 Inadequate Treatment/Disease Progression The worsening of a disease over time due to inadequate treatment. Inadequate Treatment/Disease Progression 4651 The worsening of a disease over time due to inadequate treatment. IMDRF:F1006 A C54577 CDRH Component Code Terminology C187378 Insufficient Information to Classify Device There is not yet enough information available to classify the medical device component. Insufficient Information 4776 There is not yet enough information available to classify the medical device component. IMDRF:G07003 C C54451 CDRH Medical Device Problem Code Terminology C133498 Component Misassembled A device is found to have one or more components incorrectly assembled when delivered to the user facility. Component Misassembled 4004 A device found to have one or more components incorrectly assembled when delivered to the user facility. This includes cases in which components are interchanged. IMDRF:A020601 C C54451 CDRH Medical Device Problem Code Terminology C63127 Gas/Air Leak Problem associated with the unintended escape of a gas/air from the container in which it is housed. This also includes both external and internal air/gas leak. Gas/Air Leak 2946 Problem associated with the unintended escape of a gas/air from the container in which it is housed. This also includes both external and internal air/gas leak. IMDRF:A050402 C C54451 CDRH Medical Device Problem Code Terminology C133578 Application Program Freezes, Becomes Nonfunctional Problem associated with freezing and/or becoming nonfunctional of an application program. Application Program Freezes, Becomes Nonfunctional 4031 Problem associated with freezing and/or becoming nonfunctional of an application program. IMDRF:A110201 C C54450 CDRH Health Effect - Clinical Code Terminology C34670 Heartburn Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux. Heartburn/Indigestion 1883 Abdominal discomfort with retrosternal pain usually associated with gastroesophageal reflux, pyrosis or dyspepsia. IMDRF:E1025 C C54450 CDRH Health Effect - Clinical Code Terminology C50530 Diabetic Ketoacidosis The metabolic condition resulted from uncontrolled diabetes mellitus, in which the shift of acid-base status of the body toward the acid side because of loss of base or retention of acids other than carbonic acid is accompanied by the accumulation of ketone bodies in body tissues and fluids. Elevated Ketones/Diabetic Ketoacidosis 2364 Elevated ketones, including metabolic acidosis produced by accumulation of ketone bodies resulting from uncontrolled diabetes mellitus. IMDRF:E120501 C C54450 CDRH Health Effect - Clinical Code Terminology C172007 Metallosis Aseptic fibrosis or local necrosis secondary to metal corrosion and release of wear debris. Metal Related Pathology 4530 Also known as Metallosis. Includes trunnionosis, aseptic fibrosis or local necrosis secondary to metal corrosion and release of wear debris. IMDRF:E1618 C C54450 CDRH Health Effect - Clinical Code Terminology C187370 Limb Pain Pain in the arm(s) and/or leg(s). Limb Pain 4836 Pain in the arms and/or legs. IMDRF:E1641 C C54450 CDRH Health Effect - Clinical Code Terminology C78610 Skin Hypopigmentation Abnormal lightening of skin due to decreased melanin production or deposition. Vitiligo, albinism, and leukoderma are among the disorders that are associated with skin hypopigmentation. Hypopigmentation 4838 Abnormal lightening of skin due to decreased melanin production or deposition. IMDRF:E171603 C C54450 CDRH Health Effect - Clinical Code Terminology C83472 Skin Maceration Softening and whitening of the skin due to excessive moisture. Skin Maceration 4841 Softening of tissue by the action of a liquid. Occurs at the wound site/surrounding areas due to excessive moisture from exudate or products applied. IMDRF:E1726 C C54450 CDRH Health Effect - Clinical Code Terminology C139012 Breast Implant-Associated Anaplastic Large Cell Lymphoma A rare anaplastic large cell lymphoma that can develop following breast implants. It has been reported in patients with saline-and silicone-filled implants. It usually presents as an accumulation of seroma fluid between the implant and the surrounding fibrous capsule. The median interval from the time of the implant to the development of lymphoma is approximately 10 years. Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) 4549 A non-Hodgkin lymphoma which is associated with breast implants, and consists of large anaplastic cells. The WHO diagnostic criteria for BIA-ALCL includes positive expression of CD30 (CD30+) and negativity for anaplastic lymphoma kinase (ALK-). IMDRF:E180102 C C54450 CDRH Health Effect - Clinical Code Terminology C187373 Peri-prosthetic Joint Infection Infection around an implant following joint replacement. Peri-prosthetic Joint Infection 4845 Infection around an implant following joint replacement. IMDRF:E2123 C C54450 CDRH Health Effect - Clinical Code Terminology C187381 Radiolucent Lines An xray finding that indicates a void or area of tissue that is less dense. Radiolucent lines can be prognostic factors after surgical joint replacements. Radiolucent Lines 4848 Radiolucencies observed on x-ray. IMDRF:E2207 C C54450 CDRH Health Effect - Clinical Code Terminology C49052 Joint Effusion Abnormally increased amount of fluid in a joint cavity, usually as a result of joint inflammation. Joint effusion 4849 An abnormal collection of fluid in hollow spaces or between tissues of the joints. IMDRF:E233802 C C171094 CDRH Health Effect - Impact Code Terminology C187377 Exposure to Contaminated Device/Risk of Infection Exposure to a non-sterile device or conditions where infection is likely. Exposure to Contaminated Device/Risk of Infection 4652 Exposure to a non-sterile device or conditions where infection is likely. IMDRF:F1007 C C54451 CDRH Medical Device Problem Code Terminology C133496 Patient-Device Interaction Problem Problem related to the interaction between the patient and a medical device. Patient Device Interaction Problem 4001 Problem related to the interaction between the patient and the device. IMDRF:A01 C C54451 CDRH Medical Device Problem Code Terminology C63058 Leak/Splash Problem associated with the escape of a liquid or gas from the vessel or container in which it is housed. Leak/Splash 1354 Problem associated with the escape of a liquid (including blood and bodily fluids), gas or radiation from the vessel or container in which it is housed. IMDRF:A0504 C C54451 CDRH Medical Device Problem Code Terminology C63264 Use of Incorrect Control/Treatment Settings Problem associated with the use of the device in terms of inappropriate or incorrect control settings or incorrect treatment parameters for the device's specified operation and/or intended use. Use of Incorrect Control Settings 1126 Problem associated with the use of the device in terms of inappropriate or incorrect control settings or incorrect treatment parameters for the device's specified operation and/or intended use. IMDRF:A2302 C C54450 CDRH Health Effect - Clinical Code Terminology C50529 Delayed Union Fracture A bone fracture that is taking an abnormally long time to heal. Nonunion/Delayed-union Bone Fracture 2369 Broken bone that doesn't heal or is delayed in healing. IMDRF:E1625 C C54450 CDRH Health Effect - Clinical Code Terminology C163003 Non-Malignant Neoplasm A category that includes benign neoplasms and neoplasms with uncertain malignant potential. The latter are characterized by clinicopathological features that are not benign, including some degree of mild or mild/moderate atypia/dysplasia, but lack overt malignant morphologic characteristics and there is no evidence of metastasis at the time of diagnosis. Non-malignant Neoplasm 4842 A new and abnormal growth of tissue in a part of the body which is not indicative of malignant disorder. Can include benign tumors. IMDRF:E1805 C C54451 CDRH Medical Device Problem Code Terminology C62919 Patient-Device Incompatibility Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device. Patient-Device Incompatibility 2682 Problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device. IMDRF:A0101 C C54451 CDRH Medical Device Problem Code Terminology C63137 Fluid/Blood Leak Escape (Release, Discharge) of fluid (including blood or bodily fluid) through an unintended location; often accompanied by a loss of pressure and/or output. This includes both external and internal fluid leak. This does not include fluidized powder leak. Fluid/Blood Leak 1250 Escape (Release, Discharge) of fluid (including blood or bodily fluid) through an unintended location; often accompanied by a loss of pressure and/or output. This includes both external and internal fluid leak. This does not include fluidized powder leak. IMDRF:A050401 C C91800 CDRH Cause Investigation - Type of Investigation Terminology C139449 Testing of Device from Other Lot/Batch Returned from User The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the technical file. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the latest relevant standards. Testing of Device from Other Lot/Batch Returned From User 4103 The investigation employed relevant empirical testing of the device of another lot or batch than that of the suspected device in the reported adverse event in order to support the identification of possible causes for the adverse event. This includes devices without a lot/batch designation. The device was returned from the user. Relevant testing would typically be based on test methods used for evaluating safety and performance as described in the technical file or in the latest relevant standards. IMDRF:B05 C C54450 CDRH Health Effect - Clinical Code Terminology C162110 Low Leukocyte Count A lower than average level of leukocytes in a sample. Low White Blood Cell Count 4433 The white blood cell count is below the normal range, including neutropenia. IMDRF:E0309 C C54450 CDRH Health Effect - Clinical Code Terminology C26791 Hemorrhage The flow of blood from a ruptured blood vessel. Hemorrhage/Blood Loss/Bleeding 1888 The loss of blood from the circulation, including blood loss from a device connected to a patient. IMDRF:E0506 C C54451 CDRH Medical Device Problem Code Terminology C63294 Biocompatibility Problem associated with undesirable local or systemic effects due to exposure to device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them. Biocompatibility 2886 Problem associated with undesirable local or systemic effects due to exposure to medical device materials or leachates from those materials by a patient who has an implant or is receiving treatment with a device made from them. IMDRF:A010101