D	C54451	CDRH Medical Device Problem Code Terminology	C62880	Pacer Found in Back-Up Mode	A device with a pacing function found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device-malfunction or due to operator error.	Pacemaker Found in Back-Up Mode	1440	A device with a pacing function found in back-up Mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device malfunction or due to operator error.	IMDRF:A071205
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187286	Eye Irritation	A generic term used to describe abnormal sensations that bother the eyes like dryness, itchiness, burning and grittiness.	Eye Irritation	4803	A generic term used to describe abnormal sensations that bother the eyes like dryness, itchiness, burning and grittiness.	IMDRF:E0845
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193466	Anaphylactoid/Anaphylaxis	Acute immune response that occurs from exposure to an allergen. It can be anaphylaxis or like anaphylaxis	Anaphylactoid / Anaphylaxis	2218	Acute immune response that occurs from exposure to an allergen. For conditions which have progressed to systemic shock, use E040201 - Anaphylactic Shock.	IMDRF:E040202
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C198677	Urinary Frequency / Polyuria	Urination at short intervals or at higher volumes; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation.	Urinary Frequency / Polyuria	2275	Urination at short intervals or at higher volumes; it may result from increased urine formation, decreased bladder capacity, or lower urinary tract irritation.	IMDRF:E1308
C	C91800	Cause Investigation - Type of Investigation	C139458	Analysis of Information Provided by User/Third Party	The investigation involved the analysis of relevant information provided by the user (e.g. healthcare professional, patient, clinical engineer) or a third party (e.g. testing facility) in view of supporting the identification of possible causes for the adverse event.	Analysis of Information Provided by User/Third Party	4112	The investigation involved the analysis of relevant information provided by the user (e.g. healthcare professional, patient, clinical engineer) or a third party (e.g. testing facility) in view of supporting the identification of possible causes for the adverse event. This does not include information recorded by the device.	IMDRF:B15
C	C91801	Cause Investigation - Investigation Findings	C92052	Failure to Calibrate or Used Out of Calibration	A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) or is used out of calibration to ensure accurate readings.	Failure to Calibrate or Used Out of Calibration	3250	A device that cannot calibrate (establish the relationship between a measuring device and the units of measure) or is used out of calibration to ensure accurate readings.	IMDRF:C1302
C	C91801	Cause Investigation - Investigation Findings	C139503	Packaging Contains Incorrect or Incomplete Device	Problems that occurred because the packaging contained an incorrect or incomplete device (missing components).	Packaging Contains Incorrect or Incomplete Device	4245	Problems that occurred because the packaging contained an incorrect or incomplete device (missing components).	IMDRF:C160504
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C171950	Cardiovascular Dysfunction / Insufficiency	Circulatory dysfunction and/or insufficiency due to a decrease in the force of the cardiac contractions and/or the tone of the vascular walls.	Cardiovascular Dysfunction / Insufficiency	4445	Circulatory dysfunction/insufficiency due to a decrease in the force of the cardiac contractions and / or the tone of the vascular walls. Includes diastolic and systolic dysfunction.	IMDRF:E0607
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50705	Wound Infection	Infection of a break in the skin or other tissue.	Wound Infection	2447	Infection of a wound. This does not include post surgical wound infection.	IMDRF:E2012
C	C54577	Medical Device Component	C171947	Cable Grip/Tie Device	Component used for tensioning, pulling, holding or stringing of wires and cables.	Cable Grip/Tie	4705	Component used for tensioning, pulling, holding or stringing of wires and cables.	IMDRF:G0200401
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C75568	Multiple Organ Failure	Complete impairment of two or more organs or organ systems.	Multiple Organ Dysfunction Syndrome	3261	Complete impairment of two or more organs or organ systems. Also known as multiple organ failure.	IMDRF:E2342
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193465	Ambulation or Postural Difficulties	Any persistent problem with walking, gait or maintaining posture (sitting, standing).	Ambulation Difficulties	2544	Any persistent problem with walking, gait or maintaining posture (sitting, standing).	IMDRF:E2302
C	C54451	Medical Device Problem	C63007	Electrical/Electronic Property Problem	Problem associated with the function of the electrical circuitry of the device.	Electrical /Electronic Property Problem	1198	Problem associated with the function of the electrical circuitry of the device.	IMDRF:A07
C	C54451	Medical Device Problem	C63075	Infusion or Flow Problem	Problem associated with the device failing to deliver or draw liquids or gases as intended (e.g. delivering drugs at incorrect rate, problems with drawing fluid from a system). This includes vacuum collection devices and manual or mechanical pumps.	Infusion or Flow Problem	2964	Problem associated with the device failing to deliver or draw liquids or gases as intended (e.g. delivering drugs at incorrect rate, problems with drawing fluid from a system). This includes vacuum collection devices and manual or mechanical pumps.	IMDRF:A14
C	C54451	Medical Device Problem	C62860	Pumping Problem	Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion or dispensing.	Pumping Problem	3016	Problem associated with pump performance deviating from specifications in a way to compromise flow or infusion or dispensing.	IMDRF:A1412
C	C91800	Cause Investigation - Type of Investigation	C139459	Device Not Manufactured by Reporting Manufacturer	Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. This includes mistaken identity or falsified device.	Device Not Manufactured by Reporting Manufacturer	4113	Further information was obtained which established that the manufacturer of the device involved was not the one to which it was initially attributed. This includes mistaken identity or falsified device. Use in conjunction with C20 and D13 or D14.	IMDRF:B16
C	C91800	Cause Investigation - Type of Investigation	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, includes device interrogation.	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, includes device interrogation.	IMDRF:B24
C	C54451	Medical Device Problem	C62876	Perivalvular Leak	Problem associated with the escape of blood around a heart valve, particularly around its leaflets.	Perivalvular Leak	1457	Problem associated with the escape of blood around a heart valve, particularly around its leaflets. Also known as paravalvular leak.	IMDRF:A050405
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50592	Hyphema	Hemorrhage within the anterior chamber of the eye; bloodshot.	Hyphema	1911	Hemorrhage within the anterior chamber of the eye.	IMDRF:E0824
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50618	Intraocular Pressure Increased	Increased pressure of the intraocular fluid in the eye.	Intraocular Pressure Increased	1937	Increase of pressure of the intraocular fluid in the eye, also known as ocular hypertension.	IMDRF:E0827
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C128346	Transmissible Spongiform Encephalopathy	A transmissible, infectious disease that is caused by a protein that is able to induce abnormal folding of normal cellular proteins, leading to characteristic spongiform brain changes, which are associated with neuronal loss without an inflammatory response. Such disorders have typically long incubation periods, but are then generally rapidly progressive and are uniformly fatal.	Transmissible Spongiform Encephalopathy(TSE)	4556	A group of rare degenerative brain disorders associated with prions for example Creutzfeldt-Jakob disease (CJD) or Bovine Spongiform Encephalopathy (BSE).	IMDRF:E1905
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50588	Hyperemia	The presence of an increased amount of blood in a part or organ; engorgement.	Hyperemia	1904	The presence of an increased amount of blood in a part or organ; engorgement or bloodshot.	IMDRF:E2322
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C172137	Insufficient Information to Classify Condition	Not enough information available to classify the clinical signs, symptoms and conditions.	Insufficient Information	4580	It is not clear whether any health effects occurred, or health effect appears to have occurred but there is not yet enough information available to classify the clinical signs, symptoms and conditions.	IMDRF:E2401
C	C171094	Health Effects - Health Impact	C172008	Minor Injury/ Illness/Impairment	A mild injury, illness or impairment which can be treated with minimal or no intervention.	Minor Injury/ Illness / Impairment	4613	A mild injury, illness or impairment which can be treated with minimal or no intervention, including monitoring only.	IMDRF:F11
C	C171094	Health Effects - Health Impact	C15329	Surgical Procedure	A diagnostic or treatment procedure performed by manual and/or instrumental means, often involving an incision and the removal or replacement of a diseased organ or tissue; of or relating to or involving or used in surgery or requiring or amenable to treatment by surgery.	Surgical Intervention	4624	One or more surgical procedures, including percutaneous or minimally invasive procedures, were required, or an existing procedure changed.	IMDRF:F19
C	C171094	Health Effects - Health Impact	C172010	More Complex Surgery	Surgery that is more complicated, more comprehensive or more extensive than planned.	More Complex Surgery	4631	Surgery that is more complicated, more comprehensive or more extensive than planned (e.g. percutaneous to open surgery).	IMDRF:F1907
C	C171094	Health Effects - Health Impact	C172138	Insufficient Information to Classify Health Impact	Not enough information available to classify the health impact.	Insufficient Information	4648	It is not clear whether any health impact occurred, or health impact appears to have occurred, but there is not yet enough information available to classify the health impact.	IMDRF:F24
C	C54577	Medical Device Component	C50106	Plate Device	A sheet of metal or wood or glass or plastic.	Plate	907	A thin, flat sheet or strip used to join, strengthen or to form parts of another structure. For a flat, shallow container with a raised rim, use G03016 - Tray.	IMDRF:G04097
C	C171094	Health Effects - Health Impact	C198673	Additional or Unexpected Endoscopic Procedure		Endoscopic Diagnostic Procedure	4638	Patient required additional or unexpected endoscopic procedure.	IMDRF:F2202
C	C91802	Cause Investigation - Investigation Conclusion	C139470	Cause Traced to Non-Device Related Factors 	The adverse event that occurred is not attributable to a device.	Cause Traced to Non-Device Related Factors	4310	The adverse event that occurred is confirmed to have been caused by something other than the device or usage.	IMDRF:D10
C	C91802	Cause Investigation - Investigation Conclusion	C177435	Cause Linked to Device but Unable to Trace More Specifically	Problems traced to the device, but the investigation could not identify the actual root cause (e.g. Design, Manufacturing, Component).	Cause Linked to Device but Unable to Trace More Specifically	44	Problems traced to the device, but the investigation could not identify the actual root cause (e.g. Design, Manufacturing, Component).	IMDRF:D1501
C	C54451	Medical Device Problem	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/Treatment 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	Health Effects - Clinical Signs and Symptoms or Conditions	C187268	Increased Intracranial Pressure	Pressure within the craniospinal compartment is increased.	Intracranial Pressure Increased	4586	Pressure within the craniospinal compartment is increased.	IMDRF:E0140
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	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
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187275	Abnormal Blood Protein	One or more of the blood protein levels being higher or lower than normal (e.g. Albumin, C-reactive Protein).	Blood Protein Abnormal	4595	One or more of the blood protein levels being higher or lower than normal (e.g. Albumin, C-reactive Protein).	IMDRF:E0313
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C187276	Expanding Aneurysm	Expansion of aneurysm.	Aneurysm expansion	4597	Expansion of aneurysm.	IMDRF:E050102
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	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
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	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.	Infectious Otitis Externa	4814	An infectious process involving the outer ear and ear canal.	IMDRF:E090801
C	C54577	Medical Device Component	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	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C50591	Hypervolemia	Fluid accumulation in tissues and body cavities.	Hypervolemia	2664	An abnormally high circulating blood volume.	IMDRF:E0304
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C9305	Malignant Neoplasm	A neoplasm composed of atypical neoplastic, often pleomorphic cells that invade other tissues. Malignant neoplasms often metastasize to distant anatomic sites and may recur after excision. The most common malignant neoplasms are carcinomas, Hodgkin and non-Hodgkin lymphomas, leukemias, melanomas, and sarcomas.	Cancer	3262	A group of diseases in which abnormal cells divide without control, invade nearby tissues and may also spread to other parts of the body through the blood and lymph systems.	IMDRF:E1801
C	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C139012	Breast Implant-Associated Anaplastic Large Cell Lymphoma	A rare anaplastic large cell lymphoma that develops in individuals with breast 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	Health Effects - Clinical Signs and Symptoms or Conditions	C2885	Peritoneal Effusion	The accumulation of fluid in the peritoneal cavity, which may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum.	Ascites	2596	Accumulation of fluid in the peritoneal cavity. The fluid may be serous, hemorrhagic, or the result of tumor metastasis to the peritoneum.	IMDRF:E1004
A	C54451	Medical Device Problem	C193377	Post-EVAR Endoleak	Problem associated with persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure.	Endoleaks	4074	Problem associated with persistent blood flow/pressure in the aneurysm sac following an endovascular aneurysm repair (EVAR) procedure.	IMDRF:A050408
A	C54451	Medical Device Problem	C193378	Damaged Thread	Problems associated with threads that are damaged either prior to use due to bad threading or repeated re-use (possibly with other damaged components) or threads that became stripped or damaged while being used.	Damaged Thread	4075	Problems associated with threads that are damaged either prior to use due to bad threading or repeated re-use (possibly with other damaged components) or threads that became stripped or damaged while being used.	IMDRF:A0514
A	C54451	Medical Device Problem	C193379	Device in back-up Mode	A device found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device malfunction or due to operator error.	Device in Backup-mode	4076	A device found in back-up mode. This may be an appropriate fail-safe action (e.g. end of battery life), or be caused by device malfunction or due to operator error.	IMDRF:A0723
A	C54451	Medical Device Problem	C193380	Prophylactic Removal due to Corrective Action	Prophylactic removal of a device due to corrective action without malfunction or problem of the specific device involved.	Prophylactic removal due to corrective action	4077	Prophylactic removal of a device due to corrective action without malfunction or problem of the specific device involved	IMDRF:A2501
A	C91800	Cause Investigation - Type of Investigation	C193381	Particulate Testing	Analysis of particulate or foreign material returned from user for evaluation.	Particulate Testing	4122	Analysis of particulate or foreign material returned from user for evaluation.	IMDRF:B25
A	C91801	Cause Investigation - Investigation Findings	C193382	Undesirable Presence of Endogenous Materials	Undesirable presence of endogenous substances, body fluids, cellular tissues, etc.	Undesirable Presence of Endogenous Materials	4251	Undesirable presence of endogenous substances, body fluids, cellular tissues, etc.	IMDRF:C0109
A	C91801	Cause Investigation - Investigation Findings	C193383	Corrupted Memory	Malfunction that resulted from a device memory corruption, including bit flips or single event errors.	Corrupted memory	4252	Malfunction that resulted from a device memory corruption, including bit flips or single event errors.	IMDRF:C0210
A	C91801	Cause Investigation - Investigation Findings	C193384	Blockage Identified	Problems that occurred due to an obstruction or blockage.	Blockage Identified	4253	Problems that occurred due to an obstruction or blockage.	IMDRF:C0708
A	C91801	Cause Investigation - Investigation Findings	C131121	Insufficient Sample Volume	An indication that there was not enough sample available.	Insufficient Sample Volume	4254	Not having a sufficient volume of sample to perform a test.	IMDRF:C2301
A	C91801	Cause Investigation - Investigation Findings	C193385	Use of Non-Validated Controls Identified	Problems that occur related to the use of non-validated controls.	Use of Non-Validated Controls Identified	4255	Problems that occur related to the use of non-validated controls.	IMDRF:C2302
A	C91801	Cause Investigation - Investigation Findings	C193386	Malfunction Observed Without Conclusive Finding	Malfunction was verified but no conclusive finding is available.	Malfunction Observed Without Conclusive Finding	4256	Malfunction was verified but no conclusive finding is available.	IMDRF:C24
A	C91802	Cause Investigation - Investigation Conclusion	C193387	Cause Traced to Another Device	Problem is traced to be caused by another device.	Cause Traced to Another Device	40	Problem is traced to be caused by another device.	IMDRF:D20
A	C91802	Cause Investigation - Investigation Conclusion	C193388	Cause Traced to Health Disparity	Problems traced to device performing inadequately or inconsistently in people with certain equality characteristics (e.g. sex, racial or ethnic origin).	Cause Traced to Health Disparity	4321	Problems traced to device performing inadequately or inconsistently in people with certain equality characteristics (e.g. sex, racial or ethnic origin).	IMDRF:D21
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C198676	Sleepiness / Drowsiness / Somnolence	To have difficulties staying awake or being difficult to arouse.	Sleepiness/Drowsiness/Somnolence	4850	The sensation of struggling to remain awake.	IMDRF:E0209
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193389	Reperfusion Injury	Tissue damage caused when blood supply returns to tissue after a period of ischemia or lack of oxygen. The restoration of circulation results in inflammation and oxidative damage.	Reperfusion Injury	4851	Tissue damage caused when blood supply returns to tissue after a period of ischemia or lack of oxygen. The restoration of circulation results in inflammation and oxidative damage.	IMDRF:E0520
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193390	Intraoperative Cardiac Valve Injury	An intraoperative event that causes abnormal valve function; this is usually a tear in the leaflet or the chordae tendinae.	Intraoperative Cardiac Valve Injury	4852	An intraoperative event that causes abnormal valve function; this is usually a tear in the leaflet or the chordae tendinae.	IMDRF:E0624
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193391	Cardiac Septal Defect Residual Shunt	Irregular blood flow in the heart after surgical correction of a septal defect.	Cardiac Septal Defect Residual Shunt	4853	Irregular blood flow in the heart after surgical correction of a septal defect.	IMDRF:E0625
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193392	Transvalvular Pressure Gradient Increased	Increased pressure across the heart valve.	Transvalvular Pressure Gradient Increased	4854	Increased pressure across the heart valve	IMDRF:E0626
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78377	Intraoperative Cardiac Injury	Damage to the heart during a surgical procedure.	Intraoperative Cardiac Injury	4855	An intraoperative event that causes abnormal cardiac function. For valvular injury, use E0624 - Intraoperative Cardiac Valve Injury	IMDRF:E0627
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193441	Mydriasis	The pupil(s) are dilated.	Mydriasis	4856	Dilated pupils	IMDRF:E0854
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193442	Anterior Capsule Opacification	Remnant lens epithelial cell proliferation of the anterior capsule.	Anterior Capsule Opacification	4857	Remnant lens epithelial cell proliferation of the anterior capsule.	IMDRF:E0855
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193440	Pupillary Disorder	Condition which affects the structures or function of the pupil of the eye.	Pupillary Disorder	4858	Condition which affects the structures or function of the pupil of the eye.	IMDRF:E0856
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193443	Corneal Warpage	A change in the shape of the corneal surface presenting as abnormal radial symmetry.	Corneal Warpage	4859	A change in the shape of the corneal surface presenting as abnormal radial symmetry.	IMDRF:E0857
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C84354	Infectious Otitis Media	Inflammation of the anatomical structures of the middle ear secondary to an infectious process. Bacterial etiology is most common, but both viral and fungal pathogens are also possible. Symptoms include erythema and edema of the tympanic membrane, pain, and possibly fever. In severe infections, inflammation and edema of the structures of the middle ear can lead to perforation of the tympanic membrane secondary to the buildup of pressure in the narrow space.	Infectious Otitis Media	4815	An infectious process involving the middle ear, includes acute otitis media, chronic otitis media, chronic suppurative otitis media, otitis media with effusion (OME), etc.	IMDRF:E090802
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C26800	Hypothyroidism	Abnormally low levels of thyroid hormone.	Hypothyroidism	4860	Abnormally low levels of thyroid hormone.	IMDRF:E1212
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C114688	Urolithiasis	Stone(s) within the urinary tract.	Urolithiasis	4861	A condition arising from the formation of renal calculi (e.g. kidney stones, bladder stones, urinary tract stones).	IMDRF:E1312
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C27189	Interstitial Cystitis	Inflammation of the urinary bladder wall leading to urinary frequency, urgency, and discomfort, pelvic pain, and pain during intercourse. Morphologically it is characterized by a transmural bladder inflammatory infiltrate containing mast cells.	Interstitial Cystitis	4862	A chronic bladder condition resulting in recurring discomfort or pain in the bladder or surrounding pelvic region. Also known as Bladder Pain Syndrome (BPS).	IMDRF:E1313
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193444	Bladder Wall Thickening	Thickening of the bladder walls.	Bladder Wall Thickening	4863	Thickening of the bladder walls, including Bladder Trabeculation.	IMDRF:E1314
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C78699	Vaginal Dryness	An uncomfortable feeling of itching and burning in the vaginal opening resulting from inadequate vaginal lubrication. It is commonly seen during and after menopause, childbirth, or stressful conditions. It results in painful intercourse.	Vaginal Dryness	4864	An uncomfortable feeling of itching and burning in the vaginal opening resulting from inadequate vaginal lubrication.	IMDRF:E1419
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C40122	Pelvic Pain	Painful sensation in the pelvis.	Pelvic Pain	4865	Pain in the pelvic area	IMDRF:E1420
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193445	Wound Odor	Malodorous smell of the wound.	Wound Odor	4866	Malodor of the wound or skin not otherwise explained. Can include odors due to necrosis, bioburden or other barriers to wound healing.	IMDRF:E1727
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C193446	Unintended Loss of Vascular Access	The accidental removal of a previously inserted line from a blood vessel.	Unintended Loss of Vascular Access	4867	The accidental removal of a previously inserted line from a blood vessel.	IMDRF:E2124
A	C54450	Health Effects - Clinical Signs and Symptoms or Conditions	C99536	Hemodynamic Instability	A state of hypoperfusion that does not support normal organ perfusion or function. It can include periods of reduced, unstable, or abnormal blood pressure with near syncope, or episodes of syncope.	Hemodynamic instability	4868	Abnormal or unstable blood pressure	IMDRF:E2343
A	C171094	Health Effects - Health Impact	C193439	Reprogramming of Device	Patient required programming changes to be made to an implantable or other programmable device.	Reprogramming of Device	4653	Patient required programming changes to be made to an implantable or other programmable device.	IMDRF:F2307
A	C54577	Medical Device Component	C193447	Firmware	Computer instructions and data that reside as read-only software on that device. The computer cannot modify such software during processing.	Firmware	4777	Computer instructions and data that reside as read-only software on that device.The computer cannot modify such software during processing.	IMDRF:G0200804
A	C54577	Medical Device Component	C193448	Control Material	A standard or reference material used for the purposes of comparative evaluations.	Control Material	4778	A standard or reference material used for the purposes of comparative evaluations.	IMDRF:G03014
A	C54577	Medical Device Component	C17627	Swab	A tuft of material on the end of a stick for applying solutions and suspensions	Swab	4779	An absorbent pad or piece of material attached to the end of a stick typically used for applying medicines or taking specimens.	IMDRF:G03015
A	C54577	Medical Device Component	C53438	Tray	A shallow flat receptacle, with a raised edge or rim, used for carrying, holding, or displaying finished drug product in its primary or market package. A tray and its contents may be encased in shrink-wrapped plastic for shipping, or with a cover or an overwrap as part of a unit of use package or kit.	Tray	4780	A flat, shallow container with a raised rim.	IMDRF:G03016