Source Subset Code Subset Name Concept Code Source PT Source Definition Source Synonym(s) FDA C54583 Adverse Event Outcome ICSR Terminology C49489 Adverse Event Outcome Outcome Attributed to Adverse Event FDA C54583 Adverse Event Outcome ICSR Terminology C2849 CONGENITAL DEFECT/DEFORMITY DEFECT/DEFORMITY, CONGENITAL|DEFORMITY/DEFECT, CONGENITAL FDA C54583 Adverse Event Outcome ICSR Terminology C28554 DEATH EXPIRED/DEATH|DIED FDA C54583 Adverse Event Outcome ICSR Terminology C21007 DISABILITY FDA C54583 Adverse Event Outcome ICSR Terminology C25179 Hospitalization FDA C54583 Adverse Event Outcome ICSR Terminology C52668 Intervention Required FDA C54583 Adverse Event Outcome ICSR Terminology C50913 Invalid Data FDA C54583 Adverse Event Outcome ICSR Terminology C41337 Life Threatening Life Threatening Adverse Event FDA C54583 Adverse Event Outcome ICSR Terminology C60812 Multiple Deaths And Serious Injuries FDA C54583 Adverse Event Outcome ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54583 Adverse Event Outcome ICSR Terminology C48660 NOT APPLICABLE FDA C54583 Adverse Event Outcome ICSR Terminology C17649 OTHER Other FDA C54583 Adverse Event Outcome ICSR Terminology C60811 Pediatric Death FDA C54583 Adverse Event Outcome ICSR Terminology C17998 UNKNOWN Unknown FDA C54595 Device Usage ICSR Terminology C53612 Initial FDA C54595 Device Usage ICSR Terminology C53613 Reuse FDA C54595 Device Usage ICSR Terminology C17998 UNKNOWN Unknown FDA C54595 Device Usage ICSR Terminology C38046 Unspecified FDA C54595 Device Usage ICSR Terminology C53645 Usage of Device FDA C54590 Location Of Event Occurrence ICSR Terminology C16281 Ambulatory Care Facility FDA C54590 Location Of Event Occurrence ICSR Terminology C51957 Ambulatory Surgical Center FDA C54590 Location Of Event Occurrence ICSR Terminology C51945 Ambulatory Surgical Facility Outpatient Clinic/Surgery FDA C54590 Location Of Event Occurrence ICSR Terminology C51963 Blood Bank FDA C54590 Location Of Event Occurrence ICSR Terminology C51964 Bloodmobile FDA C54590 Location Of Event Occurrence ICSR Terminology C53510 Cardiac Catheterization Suite Catheterization Suite FDA C54590 Location Of Event Occurrence ICSR Terminology C51967 Chemotherapy Center FDA C54590 Location Of Event Occurrence ICSR Terminology C51282 Clinic - Walk in, Other FDA C54590 Location Of Event Occurrence ICSR Terminology C53518 Dialysis Center FDA C54590 Location Of Event Occurrence ICSR Terminology C53512 Dialysis Unit FDA C54590 Location Of Event Occurrence ICSR Terminology C53519 Drug Clinic FDA C54590 Location Of Event Occurrence ICSR Terminology C53513 Emergency Room FDA C54590 Location Of Event Occurrence ICSR Terminology C53514 Examination Room FDA C54590 Location Of Event Occurrence ICSR Terminology C51966 Free-Standing Cardiac Catheterization Laboratory FDA C54590 Location Of Event Occurrence ICSR Terminology C18002 Home FDA C54590 Location Of Event Occurrence ICSR Terminology C53532 Hospice FDA C54590 Location Of Event Occurrence ICSR Terminology C16696 Hospital FDA C54590 Location Of Event Occurrence ICSR Terminology C53521 Imaging Center - Mobile FDA C54590 Location Of Event Occurrence ICSR Terminology C53538 In Transit to User/Medical Facility FDA C54590 Location Of Event Occurrence ICSR Terminology C53511 Intensive Care Unit Critical Care Unit FDA C54590 Location Of Event Occurrence ICSR Terminology C50913 Invalid Data FDA C54590 Location Of Event Occurrence ICSR Terminology C37984 Laboratory FDA C54590 Location Of Event Occurrence ICSR Terminology C53551 Laboratory or Pathology Department FDA C54590 Location Of Event Occurrence ICSR Terminology C53509 Location Where Event Occurred FDA C54590 Location Of Event Occurrence ICSR Terminology C53530 Long-Term Care Facility FDA C54590 Location Of Event Occurrence ICSR Terminology C53515 Maternity Ward - Nursery FDA C54590 Location Of Event Occurrence ICSR Terminology C53523 Mobile Health Unit FDA C54590 Location Of Event Occurrence ICSR Terminology C53524 MRI Center MRI Centers FDA C54590 Location Of Event Occurrence ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54590 Location Of Event Occurrence ICSR Terminology C48660 NOT APPLICABLE FDA C54590 Location Of Event Occurrence ICSR Terminology C53533 Nursing Home FDA C54590 Location Of Event Occurrence ICSR Terminology C53516 Operating Room FDA C54590 Location Of Event Occurrence ICSR Terminology C17649 OTHER Other FDA C54590 Location Of Event Occurrence ICSR Terminology C53541 Outdoors FDA C54590 Location Of Event Occurrence ICSR Terminology C53548 Outpatient Diagnostic Facility FDA C54590 Location Of Event Occurrence ICSR Terminology C53549 Outpatient Treatment Facility FDA C54590 Location Of Event Occurrence ICSR Terminology C53542 Park FDA C54590 Location Of Event Occurrence ICSR Terminology C53689 Playground FDA C54590 Location Of Event Occurrence ICSR Terminology C53564 Psychiatric Center-Walk in, Other FDA C54590 Location Of Event Occurrence ICSR Terminology C53536 Psychiatric Facility FDA C54590 Location Of Event Occurrence ICSR Terminology C53546 Public Building FDA C54590 Location Of Event Occurrence ICSR Terminology C53688 Public Venue FDA C54590 Location Of Event Occurrence ICSR Terminology C53517 Radiology Department FDA C54590 Location Of Event Occurrence ICSR Terminology C53535 Rehabilitation Center FDA C54590 Location Of Event Occurrence ICSR Terminology C53537 Retirement Home FDA C54590 Location Of Event Occurrence ICSR Terminology C17118 School FDA C54590 Location Of Event Occurrence ICSR Terminology C53687 Stationary Imaging Center FDA C54590 Location Of Event Occurrence ICSR Terminology C25690 Street FDA C54590 Location Of Event Occurrence ICSR Terminology C53525 Tuberculosis Clinic FDA C54590 Location Of Event Occurrence ICSR Terminology C17998 UNKNOWN Unknown FDA C54590 Location Of Event Occurrence ICSR Terminology C53528 Urgent Care Center FDA C54590 Location Of Event Occurrence ICSR Terminology C53552 Ward or Patient Room FDA C54585 Occupation ICSR Terminology C51959 Attorney FDA C54585 Occupation ICSR Terminology C51804 Audiologist FDA C54585 Occupation ICSR Terminology C51960 Biomedical Engineer FDA C54585 Occupation ICSR Terminology C53428 Dental Assistant FDA C54585 Occupation ICSR Terminology C53293 Dental Hygienist FDA C54585 Occupation ICSR Terminology C52654 Dentist FDA C54585 Occupation ICSR Terminology C28248 Dietician FDA C54585 Occupation ICSR Terminology C53417 Emergency Medical Technician FDA C54585 Occupation ICSR Terminology C53287 Health Care Professional FDA C54585 Occupation ICSR Terminology C53429 Home Health Aid FDA C54585 Occupation ICSR Terminology C53433 Hospital Service Technician FDA C54585 Occupation ICSR Terminology C50913 Invalid Data FDA C54585 Occupation ICSR Terminology C53430 Medical Assistant FDA C54585 Occupation ICSR Terminology C53442 Medical Equipment Company Technician or Representative FDA C54585 Occupation ICSR Terminology C53418 Medical Technologist FDA C54585 Occupation ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54585 Occupation ICSR Terminology C48660 NOT APPLICABLE FDA C54585 Occupation ICSR Terminology C53419 Nuclear Medicine Technologist FDA C54585 Occupation ICSR Terminology C20821 Nurse FDA C54585 Occupation ICSR Terminology C53431 Nursing Assistant FDA C54585 Occupation ICSR Terminology C25193 Occupation FDA C54585 Occupation ICSR Terminology C28174 Occupational Therapist FDA C54585 Occupation ICSR Terminology C53427 Other Caregiver FDA C54585 Occupation ICSR Terminology C53289 OTHER HEALTH CARE PROFESSIONAL Other Health Care Professional FDA C54585 Occupation ICSR Terminology C17649 OTHER Other FDA C54585 Occupation ICSR Terminology C53420 Paramedic FDA C54585 Occupation ICSR Terminology C51840 Pharmacist FDA C54585 Occupation ICSR Terminology C53421 Phlebotomist FDA C54585 Occupation ICSR Terminology C53422 Physical Therapist FDA C54585 Occupation ICSR Terminology C25741 PHYSICIAN Physician FDA C54585 Occupation ICSR Terminology C53423 Physician Assistant FDA C54585 Occupation ICSR Terminology C53446 Physicist FDA C54585 Occupation ICSR Terminology C53424 Radiologic Technologist FDA C54585 Occupation ICSR Terminology C53425 Respiratory Therapist FDA C54585 Occupation ICSR Terminology C53448 Risk Manager FDA C54585 Occupation ICSR Terminology C53441 Service and Testing Personnel FDA C54585 Occupation ICSR Terminology C53273 Service Personnel FDA C54585 Occupation ICSR Terminology C19177 Speech Therapist Unknown FDA C54585 Occupation ICSR Terminology C17998 UNKNOWN FDA C54584 Operator of Medical Device ICSR Terminology C51804 Audiologist FDA C54584 Operator of Medical Device ICSR Terminology C51960 Biomedical Engineer FDA C54584 Operator of Medical Device ICSR Terminology C53428 Dental Assistant FDA C54584 Operator of Medical Device ICSR Terminology C53293 Dental Hygienist FDA C54584 Operator of Medical Device ICSR Terminology C52654 Dentist FDA C54584 Operator of Medical Device ICSR Terminology C53274 Device Unattended FDA C54584 Operator of Medical Device ICSR Terminology C28248 Dietician FDA C54584 Operator of Medical Device ICSR Terminology C53417 Emergency Medical Technician FDA C54584 Operator of Medical Device ICSR Terminology C53287 Health Care Professional FDA C54584 Operator of Medical Device ICSR Terminology C53429 Home Health Aid FDA C54584 Operator of Medical Device ICSR Terminology C53433 Hospital Service Technician FDA C54584 Operator of Medical Device ICSR Terminology C50913 Invalid Data FDA C54584 Operator of Medical Device ICSR Terminology C53430 Medical Assistant FDA C54584 Operator of Medical Device ICSR Terminology C53442 Medical Equipment Company Technician or Representative FDA C54584 Operator of Medical Device ICSR Terminology C53418 Medical Technologist FDA C54584 Operator of Medical Device ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54584 Operator of Medical Device ICSR Terminology C48660 NOT APPLICABLE FDA C54584 Operator of Medical Device ICSR Terminology C53419 Nuclear Medicine Technologist FDA C54584 Operator of Medical Device ICSR Terminology C20821 Nurse FDA C54584 Operator of Medical Device ICSR Terminology C53431 Nursing Assistant FDA C54584 Operator of Medical Device ICSR Terminology C28174 Occupational Therapist FDA C54584 Operator of Medical Device ICSR Terminology C53272 Operator of Medical Device FDA C54584 Operator of Medical Device ICSR Terminology C53427 Other Caregiver FDA C54584 Operator of Medical Device ICSR Terminology C53289 OTHER HEALTH CARE PROFESSIONAL Other Health Care Professional FDA C54584 Operator of Medical Device ICSR Terminology C17649 OTHER Other FDA C54584 Operator of Medical Device ICSR Terminology C53420 Paramedic FDA C54584 Operator of Medical Device ICSR Terminology C53432 Patient Family Member Or Friend FDA C54584 Operator of Medical Device ICSR Terminology C16960 PATIENT Lay User/Patient|Patient FDA C54584 Operator of Medical Device ICSR Terminology C51840 Pharmacist FDA C54584 Operator of Medical Device ICSR Terminology C53421 Phlebotomist FDA C54584 Operator of Medical Device ICSR Terminology C53422 Physical Therapist FDA C54584 Operator of Medical Device ICSR Terminology C25741 PHYSICIAN Physician FDA C54584 Operator of Medical Device ICSR Terminology C53423 Physician Assistant FDA C54584 Operator of Medical Device ICSR Terminology C53446 Physicist FDA C54584 Operator of Medical Device ICSR Terminology C53424 Radiologic Technologist FDA C54584 Operator of Medical Device ICSR Terminology C53425 Respiratory Therapist FDA C54584 Operator of Medical Device ICSR Terminology C53448 Risk Manager FDA C54584 Operator of Medical Device ICSR Terminology C53441 Service and Testing Personnel FDA C54584 Operator of Medical Device ICSR Terminology C53273 Service Personnel FDA C54584 Operator of Medical Device ICSR Terminology C19177 Speech Therapist FDA C54584 Operator of Medical Device ICSR Terminology C17998 UNKNOWN Unknown FDA C54593 Reason For Non-Evaluation ICSR Terminology C53601 Device Evaluation Anticipated But Not Yet Begun FDA C54593 Reason For Non-Evaluation ICSR Terminology C53599 Device Not Made by Company FDA C54593 Reason For Non-Evaluation ICSR Terminology C53600 Device Problem Already Known No Evaluation Necessary FDA C54593 Reason For Non-Evaluation ICSR Terminology C53598 Device Received in Condition Which Made Analysis Impossible FDA C54593 Reason For Non-Evaluation ICSR Terminology C17649 OTHER Other FDA C54593 Reason For Non-Evaluation ICSR Terminology C53593 Reason for Non-Evaluation FDA C54587 Report Source ICSR Terminology C15206 Clinical Study FDA C54587 Report Source ICSR Terminology C51968 Company Representative FDA C54587 Report Source ICSR Terminology C53568 CONSUMER/CONCERNED CITIZEN Consumer FDA C54587 Report Source ICSR Terminology C48289 Distributor FDA C54587 Report Source ICSR Terminology C25512 Foreign FDA C54587 Report Source ICSR Terminology C53287 Health Care Professional FDA C54587 Report Source ICSR Terminology C50913 Invalid Data FDA C54587 Report Source ICSR Terminology C48471 Literature FDA C54587 Report Source ICSR Terminology C17649 OTHER Other FDA C54587 Report Source ICSR Terminology C53566 Report Source FDA C54587 Report Source ICSR Terminology C17998 UNKNOWN Unknown FDA C54587 Report Source ICSR Terminology C53567 User Facility Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician's office, as defined in this section. School nurse offices and employee health units are not device user facilities. FDA C54580 Type of Event ICSR Terminology C41331 Adverse Event FDA C54580 Type of Event ICSR Terminology C53054 Product Problem FDA C54580 Type of Event ICSR Terminology C53053 Type of Event Type of Reportable Event FDA C54592 Type Of Follow-Up ICSR Terminology C53586 Additional Information FDA C54592 Type Of Follow-Up ICSR Terminology C53585 Correction FDA C54592 Type Of Follow-Up ICSR Terminology C53588 Device Evaluation FDA C54592 Type Of Follow-Up ICSR Terminology C53587 Response to FDA Request FDA C54592 Type Of Follow-Up ICSR Terminology C53584 Type of Follow-Up FDA C54598 Type Of Manufacturer ICSR Terminology C53618 Original Equipment Manufacturer FDA C54598 Type Of Manufacturer ICSR Terminology C53614 Reprocessor FDA C54598 Type Of Manufacturer ICSR Terminology C54597 Type Of Manufacturer FDA C54594 Type Of Remedial Action ICSR Terminology C53604 Inspection FDA C54594 Type Of Remedial Action ICSR Terminology C50913 Invalid Data FDA C54594 Type Of Remedial Action ICSR Terminology C53606 Modification or Adjustment FDA C54594 Type Of Remedial Action ICSR Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54594 Type Of Remedial Action ICSR Terminology C25297 Notification FDA C54594 Type Of Remedial Action ICSR Terminology C17649 OTHER Other FDA C54594 Type Of Remedial Action ICSR Terminology C53607 Patient Monitoring FDA C54594 Type Of Remedial Action ICSR Terminology C53609 Recall Recalls are regulatory actions that enable FDA to remove a hazardous, potentially hazardous, or a misbranded product from the marketplace. Recalls are also used to convey additional information to the user concerning the safe use of the product. Either FDA or the manufacturer can initiate recalls. FDA C54594 Type Of Remedial Action ICSR Terminology C53608 Relabeling FDA C54594 Type Of Remedial Action ICSR Terminology C53611 Repair FDA C54594 Type Of Remedial Action ICSR Terminology C53610 Replacement FDA C54594 Type Of Remedial Action ICSR Terminology C53603 Type of Remedial Action FDA C54588 Type Of Report ICSR Terminology C53580 FDA Requested FDA C54588 Type Of Report ICSR Terminology C53576 Fifteen-Day FDA C54588 Type Of Report ICSR Terminology C53573 Five-Day FDA C54588 Type Of Report ICSR Terminology C53579 FOLLOW-UP Follow-Up FDA C54588 Type Of Report ICSR Terminology C53620 Initial FDA C54588 Type Of Report ICSR Terminology C53581 Manufacturer Response to Voluntary Report FDA C54588 Type Of Report ICSR Terminology C53578 PERIODIC Periodic FDA C54588 Type Of Report ICSR Terminology C53574 Seven-Day FDA C54588 Type Of Report ICSR Terminology C53575 Ten-Day FDA C54588 Type Of Report ICSR Terminology C53577 Thirty-Day FDA C54588 Type Of Report ICSR Terminology C53571 Type of Report Report Type FDA C54591 Type of Reportable Event ICSR Terminology C28554 DEATH EXPIRED/DEATH|DIED FDA C54591 Type of Reportable Event ICSR Terminology C25745 Failure FDA C54591 Type of Reportable Event ICSR Terminology C60812 Multiple Deaths And Serious Injuries FDA C54591 Type of Reportable Event ICSR Terminology C17649 OTHER Other FDA C54591 Type of Reportable Event ICSR Terminology C60811 Pediatric Death FDA C54591 Type of Reportable Event ICSR Terminology C53569 Serious Injury FDA C54591 Type of Reportable Event ICSR Terminology C53053 Type of Event Type of Reportable Event FDA C54596 Type Of Reporter ICSR Terminology C53617 Importer Any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section. FDA C54596 Type Of Reporter ICSR Terminology C25392 Manufacturer Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. FDA C54596 Type Of Reporter ICSR Terminology C53615 Type of Reporter Reporter Type FDA C54596 Type Of Reporter ICSR Terminology C53567 User Facility Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician's office, as defined in this section. School nurse offices and employee health units are not device user facilities. FDA C54447 Individual Case Safety Report Terminology C53586 Additional Information FDA C54447 Individual Case Safety Report Terminology C41331 Adverse Event FDA C54447 Individual Case Safety Report Terminology C49489 Adverse Event Outcome Outcome Attributed to Adverse Event FDA C54447 Individual Case Safety Report Terminology C25150 Age FDA C54447 Individual Case Safety Report Terminology C16281 Ambulatory Care Facility FDA C54447 Individual Case Safety Report Terminology C51957 Ambulatory Surgical Center FDA C54447 Individual Case Safety Report Terminology C51945 Ambulatory Surgical Facility Outpatient Clinic/Surgery FDA C54447 Individual Case Safety Report Terminology C53451 Approximate Age of Device FDA C54447 Individual Case Safety Report Terminology C51959 Attorney FDA C54447 Individual Case Safety Report Terminology C51804 Audiologist FDA C54447 Individual Case Safety Report Terminology C51960 Biomedical Engineer FDA C54447 Individual Case Safety Report Terminology C51963 Blood Bank FDA C54447 Individual Case Safety Report Terminology C51964 Bloodmobile FDA C54447 Individual Case Safety Report Terminology C53510 Cardiac Catheterization Suite Catheterization Suite FDA C54447 Individual Case Safety Report Terminology C51967 Chemotherapy Center FDA C54447 Individual Case Safety Report Terminology C51282 Clinic - Walk in, Other FDA C54447 Individual Case Safety Report Terminology C15206 Clinical Study FDA C54447 Individual Case Safety Report Terminology C51968 Company Representative FDA C54447 Individual Case Safety Report Terminology C2849 CONGENITAL DEFECT/DEFORMITY DEFECT/DEFORMITY, CONGENITAL|DEFORMITY/DEFECT, CONGENITAL FDA C54447 Individual Case Safety Report Terminology C53568 CONSUMER/CONCERNED CITIZEN Consumer FDA C54447 Individual Case Safety Report Terminology C53585 Correction FDA C54447 Individual Case Safety Report Terminology C53619 Corrective Action Number FDA C54447 Individual Case Safety Report Terminology C25464 Country FDA C54447 Individual Case Safety Report Terminology C53486 Date of Concomitant Therapy FDA C54447 Individual Case Safety Report Terminology C53481 Date of Device Return to Manufacturer FDA C54447 Individual Case Safety Report Terminology C28554 DEATH EXPIRED/DEATH|DIED FDA C54447 Individual Case Safety Report Terminology C53428 Dental Assistant FDA C54447 Individual Case Safety Report Terminology C53293 Dental Hygienist FDA C54447 Individual Case Safety Report Terminology C52654 Dentist FDA C54447 Individual Case Safety Report Terminology C53449 Device Available for Evaluation FDA C54447 Individual Case Safety Report Terminology C53588 Device Evaluation FDA C54447 Individual Case Safety Report Terminology C53601 Device Evaluation Anticipated But Not Yet Begun FDA C54447 Individual Case Safety Report Terminology C53602 Device Labeled for Single Use FDA C54447 Individual Case Safety Report Terminology C53599 Device Not Made by Company FDA C54447 Individual Case Safety Report Terminology C54026 Device Problem FDA C54447 Individual Case Safety Report Terminology C53600 Device Problem Already Known No Evaluation Necessary FDA C54447 Individual Case Safety Report Terminology C53598 Device Received in Condition Which Made Analysis Impossible FDA C54447 Individual Case Safety Report Terminology C53591 Device Returned to Manufacturer for Evaluation FDA C54447 Individual Case Safety Report Terminology C53274 Device Unattended FDA C54447 Individual Case Safety Report Terminology C53518 Dialysis Center FDA C54447 Individual Case Safety Report Terminology C53512 Dialysis Unit FDA C54447 Individual Case Safety Report Terminology C28248 Dietician FDA C54447 Individual Case Safety Report Terminology C21007 DISABILITY FDA C54447 Individual Case Safety Report Terminology C48289 Distributor FDA C54447 Individual Case Safety Report Terminology C53519 Drug Clinic FDA C54447 Individual Case Safety Report Terminology C53417 Emergency Medical Technician FDA C54447 Individual Case Safety Report Terminology C53513 Emergency Room FDA C54447 Individual Case Safety Report Terminology C53592 Evaluation Summary Status FDA C54447 Individual Case Safety Report Terminology C53514 Examination Room FDA C54447 Individual Case Safety Report Terminology C25745 Failure FDA C54447 Individual Case Safety Report Terminology C53580 FDA Requested FDA C54447 Individual Case Safety Report Terminology C16576 Female FDA C54447 Individual Case Safety Report Terminology C53576 Fifteen-Day FDA C54447 Individual Case Safety Report Terminology C53573 Five-Day FDA C54447 Individual Case Safety Report Terminology C53579 FOLLOW-UP Follow-Up FDA C54447 Individual Case Safety Report Terminology C25512 Foreign FDA C54447 Individual Case Safety Report Terminology C51966 Free-Standing Cardiac Catheterization Laboratory FDA C54447 Individual Case Safety Report Terminology C53287 Health Care Professional FDA C54447 Individual Case Safety Report Terminology C18002 Home FDA C54447 Individual Case Safety Report Terminology C53429 Home Health Aid FDA C54447 Individual Case Safety Report Terminology C53532 Hospice FDA C54447 Individual Case Safety Report Terminology C16696 Hospital FDA C54447 Individual Case Safety Report Terminology C53433 Hospital Service Technician FDA C54447 Individual Case Safety Report Terminology C25179 Hospitalization FDA C54447 Individual Case Safety Report Terminology C50414 Hospitalization required FDA C54447 Individual Case Safety Report Terminology C53521 Imaging Center - Mobile FDA C54447 Individual Case Safety Report Terminology C53617 Importer Any person who imports a device into the United States and who furthers the marketing of a device from the original place of manufacture to the person who makes final delivery or sale to the ultimate user, but who does not repackage or otherwise change the container, wrapper, or labeling of the device or device package. If you repackage or otherwise change the container, wrapper, or labeling, you are considered a manufacturer as defined in this section. FDA C54447 Individual Case Safety Report Terminology C53538 In Transit to User/Medical Facility FDA C54447 Individual Case Safety Report Terminology C53620 Initial FDA C54447 Individual Case Safety Report Terminology C53612 Initial FDA C54447 Individual Case Safety Report Terminology C53604 Inspection FDA C54447 Individual Case Safety Report Terminology C53511 Intensive Care Unit Critical Care Unit FDA C54447 Individual Case Safety Report Terminology C52668 Intervention Required FDA C54447 Individual Case Safety Report Terminology C50913 Invalid Data FDA C54447 Individual Case Safety Report Terminology C37984 Laboratory FDA C54447 Individual Case Safety Report Terminology C53551 Laboratory or Pathology Department FDA C54447 Individual Case Safety Report Terminology C41337 Life Threatening Life Threatening Adverse Event FDA C54447 Individual Case Safety Report Terminology C48471 Literature FDA C54447 Individual Case Safety Report Terminology C53509 Location Where Event Occurred FDA C54447 Individual Case Safety Report Terminology C53530 Long-Term Care Facility FDA C54447 Individual Case Safety Report Terminology C20197 Male FDA C54447 Individual Case Safety Report Terminology C25392 Manufacturer Manufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure. FDA C54447 Individual Case Safety Report Terminology C53581 Manufacturer Response to Voluntary Report FDA C54447 Individual Case Safety Report Terminology C53515 Maternity Ward - Nursery FDA C54447 Individual Case Safety Report Terminology C53430 Medical Assistant FDA C54447 Individual Case Safety Report Terminology C53442 Medical Equipment Company Technician or Representative FDA C54447 Individual Case Safety Report Terminology C53418 Medical Technologist FDA C54447 Individual Case Safety Report Terminology C53523 Mobile Health Unit FDA C54447 Individual Case Safety Report Terminology C53606 Modification or Adjustment FDA C54447 Individual Case Safety Report Terminology C53524 MRI Center MRI Centers FDA C54447 Individual Case Safety Report Terminology C60812 Multiple Deaths And Serious Injuries FDA C54447 Individual Case Safety Report Terminology C49487 No FDA C54447 Individual Case Safety Report Terminology C53269 NO INFORMATION NO ANSWER PROVIDED FDA C54447 Individual Case Safety Report Terminology C48660 NOT APPLICABLE FDA C54447 Individual Case Safety Report Terminology C25297 Notification FDA C54447 Individual Case Safety Report Terminology C53419 Nuclear Medicine Technologist FDA C54447 Individual Case Safety Report Terminology C20821 Nurse FDA C54447 Individual Case Safety Report Terminology C53431 Nursing Assistant FDA C54447 Individual Case Safety Report Terminology C53533 Nursing Home FDA C54447 Individual Case Safety Report Terminology C25193 Occupation FDA C54447 Individual Case Safety Report Terminology C28174 Occupational Therapist FDA C54447 Individual Case Safety Report Terminology C53516 Operating Room FDA C54447 Individual Case Safety Report Terminology C53272 Operator of Medical Device FDA C54447 Individual Case Safety Report Terminology C53618 Original Equipment Manufacturer FDA C54447 Individual Case Safety Report Terminology C53427 Other Caregiver FDA C54447 Individual Case Safety Report Terminology C53289 OTHER HEALTH CARE PROFESSIONAL Other Health Care Professional FDA C54447 Individual Case Safety Report Terminology C53263 Other Personal Medical History FDA C54447 Individual Case Safety Report Terminology C17649 OTHER Other FDA C54447 Individual Case Safety Report Terminology C53541 Outdoors FDA C54447 Individual Case Safety Report Terminology C53548 Outpatient Diagnostic Facility FDA C54447 Individual Case Safety Report Terminology C53549 Outpatient Treatment Facility FDA C54447 Individual Case Safety Report Terminology C53420 Paramedic FDA C54447 Individual Case Safety Report Terminology C53542 Park FDA C54447 Individual Case Safety Report Terminology C53432 Patient Family Member Or Friend FDA C54447 Individual Case Safety Report Terminology C53607 Patient Monitoring FDA C54447 Individual Case Safety Report Terminology C54027 PATIENT PROBLEM/MEDICAL PROBLEM PATIENT PROBLEM CODE|PATIENT PROBLEM FDA C54447 Individual Case Safety Report Terminology C16960 PATIENT Lay User/Patient|Patient FDA C54447 Individual Case Safety Report Terminology C60811 Pediatric Death FDA C54447 Individual Case Safety Report Terminology C53578 PERIODIC Periodic FDA C54447 Individual Case Safety Report Terminology C51840 Pharmacist FDA C54447 Individual Case Safety Report Terminology C53421 Phlebotomist FDA C54447 Individual Case Safety Report Terminology C53422 Physical Therapist FDA C54447 Individual Case Safety Report Terminology C25741 PHYSICIAN Physician FDA C54447 Individual Case Safety Report Terminology C53423 Physician Assistant FDA C54447 Individual Case Safety Report Terminology C53446 Physicist FDA C54447 Individual Case Safety Report Terminology C53689 Playground FDA C54447 Individual Case Safety Report Terminology C53054 Product Problem FDA C54447 Individual Case Safety Report Terminology C53564 Psychiatric Center-Walk in, Other FDA C54447 Individual Case Safety Report Terminology C53536 Psychiatric Facility FDA C54447 Individual Case Safety Report Terminology C53546 Public Building FDA C54447 Individual Case Safety Report Terminology C53688 Public Venue FDA C54447 Individual Case Safety Report Terminology C17049 Race FDA C54447 Individual Case Safety Report Terminology C53424 Radiologic Technologist FDA C54447 Individual Case Safety Report Terminology C53517 Radiology Department FDA C54447 Individual Case Safety Report Terminology C53593 Reason for Non-Evaluation FDA C54447 Individual Case Safety Report Terminology C53609 Recall Recalls are regulatory actions that enable FDA to remove a hazardous, potentially hazardous, or a misbranded product from the marketplace. Recalls are also used to convey additional information to the user concerning the safe use of the product. Either FDA or the manufacturer can initiate recalls. FDA C54447 Individual Case Safety Report Terminology C53535 Rehabilitation Center FDA C54447 Individual Case Safety Report Terminology C53608 Relabeling FDA C54447 Individual Case Safety Report Terminology C53611 Repair FDA C54447 Individual Case Safety Report Terminology C53610 Replacement FDA C54447 Individual Case Safety Report Terminology C53566 Report Source FDA C54447 Individual Case Safety Report Terminology C53614 Reprocessor FDA C54447 Individual Case Safety Report Terminology C53425 Respiratory Therapist FDA C54447 Individual Case Safety Report Terminology C53587 Response to FDA Request FDA C54447 Individual Case Safety Report Terminology C53537 Retirement Home FDA C54447 Individual Case Safety Report Terminology C53613 Reuse FDA C54447 Individual Case Safety Report Terminology C53448 Risk Manager FDA C54447 Individual Case Safety Report Terminology C17118 School FDA C54447 Individual Case Safety Report Terminology C53569 Serious Injury FDA C54447 Individual Case Safety Report Terminology C53441 Service and Testing Personnel FDA C54447 Individual Case Safety Report Terminology C53273 Service Personnel FDA C54447 Individual Case Safety Report Terminology C53574 Seven-Day FDA C54447 Individual Case Safety Report Terminology C28421 Sex FDA C54447 Individual Case Safety Report Terminology C53563 Single Use and Reused FDA C54447 Individual Case Safety Report Terminology C19177 Speech Therapist FDA C54447 Individual Case Safety Report Terminology C53687 Stationary Imaging Center FDA C54447 Individual Case Safety Report Terminology C25690 Street FDA C54447 Individual Case Safety Report Terminology C53575 Ten-Day FDA C54447 Individual Case Safety Report Terminology C36292 TEST RESULT FDA C54447 Individual Case Safety Report Terminology C53577 Thirty-Day FDA C54447 Individual Case Safety Report Terminology C53525 Tuberculosis Clinic FDA C54447 Individual Case Safety Report Terminology C53265 Type of Device FDA C54447 Individual Case Safety Report Terminology C53053 Type of Event Type of Reportable Event FDA C54447 Individual Case Safety Report Terminology C53584 Type of Follow-Up FDA C54447 Individual Case Safety Report Terminology C54597 Type Of Manufacturer FDA C54447 Individual Case Safety Report Terminology C53603 Type of Remedial Action FDA C54447 Individual Case Safety Report Terminology C53571 Type of Report Report Type FDA C54447 Individual Case Safety Report Terminology C53615 Type of Reporter Reporter Type FDA C54447 Individual Case Safety Report Terminology C17998 UNKNOWN Unknown FDA C54447 Individual Case Safety Report Terminology C38046 Unspecified FDA C54447 Individual Case Safety Report Terminology C53528 Urgent Care Center FDA C54447 Individual Case Safety Report Terminology C53645 Usage of Device FDA C54447 Individual Case Safety Report Terminology C53567 User Facility Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in this section, which is not a physician's office, as defined in this section. School nurse offices and employee health units are not device user facilities. FDA C54447 Individual Case Safety Report Terminology C53552 Ward or Patient Room FDA C54447 Individual Case Safety Report Terminology C25208 Weight FDA C54447 Individual Case Safety Report Terminology C49488 Yes