Source Subset Concept Code Source PT Source Definition Source Synonym(s) FDA Adverse_Event_Outcome_ICSR_Terminology C49489 Adverse Event Outcome Outcome Attributed to Adverse Event|Outcome of Event|OUT FDA Adverse_Event_Outcome_ICSR_Terminology C2849 Congenital Defect/Deformity Deformity/defect, congenital|Defect/deformity, congenital FDA Adverse_Event_Outcome_ICSR_Terminology C28554 Death DEATH FDA Adverse_Event_Outcome_ICSR_Terminology C21007 Disability Disability FDA Adverse_Event_Outcome_ICSR_Terminology C25179 Hospitalization FDA Adverse_Event_Outcome_ICSR_Terminology C52668 Intervention Required FDA Adverse_Event_Outcome_ICSR_Terminology C50913 Invalid Data FDA Adverse_Event_Outcome_ICSR_Terminology C41337 Life Threatening 4|Life Threatening Adverse Event|Grade 4 FDA Adverse_Event_Outcome_ICSR_Terminology C60812 Multiple Deaths And Serious Injuries FDA Adverse_Event_Outcome_ICSR_Terminology C53269 No Information Available No Answer Provided FDA Adverse_Event_Outcome_ICSR_Terminology C48660 Not Applicable NA|NOT APPLICABLE FDA Adverse_Event_Outcome_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Adverse_Event_Outcome_ICSR_Terminology C60811 Pediatric Death FDA Adverse_Event_Outcome_ICSR_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA Device_Usage_ICSR_Terminology C53612 Initial FDA Device_Usage_ICSR_Terminology C53613 Reuse FDA Device_Usage_ICSR_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA Device_Usage_ICSR_Terminology C38046 Unspecified FDA Device_Usage_ICSR_Terminology C53645 Usage of Device FDA Individual_Case_Safety_Report_Terminology C53586 Additional Information FDA Individual_Case_Safety_Report_Terminology C41331 Adverse Event ADVERSE EVENT FDA Individual_Case_Safety_Report_Terminology C49489 Adverse Event Outcome Outcome Attributed to Adverse Event|Outcome of Event|OUT FDA Individual_Case_Safety_Report_Terminology C25150 Age FDA Individual_Case_Safety_Report_Terminology C16281 Ambulatory Care Facility FDA Individual_Case_Safety_Report_Terminology C51957 Ambulatory Surgical Center FDA Individual_Case_Safety_Report_Terminology C51945 Ambulatory Surgical Facility Outpatient Clinic/Surgery FDA Individual_Case_Safety_Report_Terminology C53451 Approximate Age of Device FDA Individual_Case_Safety_Report_Terminology C51959 Attorney FDA Individual_Case_Safety_Report_Terminology C51804 Audiologist FDA Individual_Case_Safety_Report_Terminology C51960 Biomedical Engineer FDA Individual_Case_Safety_Report_Terminology C51963 Blood Bank FDA Individual_Case_Safety_Report_Terminology C51964 Bloodmobile FDA Individual_Case_Safety_Report_Terminology C53510 Cardiac Catheterization Suite Catheterization Suite FDA Individual_Case_Safety_Report_Terminology C51967 Chemotherapy Center FDA Individual_Case_Safety_Report_Terminology C51282 Clinic - Walk in, Other FDA Individual_Case_Safety_Report_Terminology C15206 Clinical Study clinical study FDA Individual_Case_Safety_Report_Terminology C51968 Company Representative FDA Individual_Case_Safety_Report_Terminology C2849 Congenital Defect/Deformity Deformity/defect, congenital|Defect/deformity, congenital FDA Individual_Case_Safety_Report_Terminology C53568 Consumer FDA Individual_Case_Safety_Report_Terminology C53585 Correction FDA Individual_Case_Safety_Report_Terminology C53619 Corrective Action Number FDA Individual_Case_Safety_Report_Terminology C25464 Country COUNTRY|Country FDA Individual_Case_Safety_Report_Terminology C53486 Date of Concomitant Therapy FDA Individual_Case_Safety_Report_Terminology C53481 Date of Device Return to Manufacturer FDA Individual_Case_Safety_Report_Terminology C28554 Death DEATH FDA Individual_Case_Safety_Report_Terminology C53428 Dental Assistant FDA Individual_Case_Safety_Report_Terminology C53293 Dental Hygienist FDA Individual_Case_Safety_Report_Terminology C52654 Dentist FDA Individual_Case_Safety_Report_Terminology C53449 Device Available for Evaluation FDA Individual_Case_Safety_Report_Terminology C53588 Device Evaluation FDA Individual_Case_Safety_Report_Terminology C53601 Device Evaluation Anticipated But Not Yet Begun FDA Individual_Case_Safety_Report_Terminology C53602 Device Labeled for Single Use FDA Individual_Case_Safety_Report_Terminology C53599 Device Not Made by Company FDA Individual_Case_Safety_Report_Terminology C54026 Device Problem FDA Individual_Case_Safety_Report_Terminology C53600 Device Problem Already Known No Evaluation Necessary FDA Individual_Case_Safety_Report_Terminology C53598 Device Received in Condition Which Made Analysis Impossible FDA Individual_Case_Safety_Report_Terminology C53591 Device Returned to Manufacturer for Evaluation FDA Individual_Case_Safety_Report_Terminology C53274 Device Unattended FDA Individual_Case_Safety_Report_Terminology C53518 Dialysis Center FDA Individual_Case_Safety_Report_Terminology C53512 Dialysis Unit FDA Individual_Case_Safety_Report_Terminology C28248 Dietician dietitian FDA Individual_Case_Safety_Report_Terminology C21007 Disability Disability FDA Individual_Case_Safety_Report_Terminology C48289 Distributor FDA Individual_Case_Safety_Report_Terminology C53519 Drug Clinic FDA Individual_Case_Safety_Report_Terminology C53417 Emergency Medical Technician FDA Individual_Case_Safety_Report_Terminology C53513 Emergency Room FDA Individual_Case_Safety_Report_Terminology C53592 Evaluation Summary Status FDA Individual_Case_Safety_Report_Terminology C53514 Examination Room FDA Individual_Case_Safety_Report_Terminology C25745 Failure FDA Individual_Case_Safety_Report_Terminology C53580 FDA Requested FDA Individual_Case_Safety_Report_Terminology C16576 Female F|Female FDA Individual_Case_Safety_Report_Terminology C53576 Fifteen-Day FDA Individual_Case_Safety_Report_Terminology C53573 Five-Day FDA Individual_Case_Safety_Report_Terminology C53579 Follow-Up FDA Individual_Case_Safety_Report_Terminology C25512 Foreign FDA Individual_Case_Safety_Report_Terminology C51966 Free-Standing Cardiac Catheterization Laboratory FDA Individual_Case_Safety_Report_Terminology C53287 Health Care Professional FDA Individual_Case_Safety_Report_Terminology C18002 Home FDA Individual_Case_Safety_Report_Terminology C53429 Home Health Aid FDA Individual_Case_Safety_Report_Terminology C53532 Hospice FDA Individual_Case_Safety_Report_Terminology C16696 Hospital FDA Individual_Case_Safety_Report_Terminology C53433 Hospital Service Technician FDA Individual_Case_Safety_Report_Terminology C25179 Hospitalization FDA Individual_Case_Safety_Report_Terminology C50414 Hospitalization Required Required hospitalization FDA Individual_Case_Safety_Report_Terminology C53521 Imaging Center - Mobile FDA 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 Individual_Case_Safety_Report_Terminology C53538 In Transit to User/Medical Facility FDA Individual_Case_Safety_Report_Terminology C53612 Initial FDA Individual_Case_Safety_Report_Terminology C53620 Initial FDA Individual_Case_Safety_Report_Terminology C53604 Inspection FDA Individual_Case_Safety_Report_Terminology C53511 Intensive Care Unit Critical Care Unit FDA Individual_Case_Safety_Report_Terminology C52668 Intervention Required FDA Individual_Case_Safety_Report_Terminology C50913 Invalid Data FDA Individual_Case_Safety_Report_Terminology C37984 Laboratory FDA Individual_Case_Safety_Report_Terminology C53551 Laboratory or Pathology Department FDA Individual_Case_Safety_Report_Terminology C41337 Life Threatening 4|Life Threatening Adverse Event|Grade 4 FDA Individual_Case_Safety_Report_Terminology C48471 Literature FDA Individual_Case_Safety_Report_Terminology C53509 Location Where Event Occurred FDA Individual_Case_Safety_Report_Terminology C53530 Long-Term Care Facility FDA Individual_Case_Safety_Report_Terminology C20197 Male Male|M FDA Individual_Case_Safety_Report_Terminology C53616 Manufacturer FDA Individual_Case_Safety_Report_Terminology C53581 Manufacturer Response to Voluntary Report FDA Individual_Case_Safety_Report_Terminology C53515 Maternity Ward - Nursery FDA Individual_Case_Safety_Report_Terminology C53430 Medical Assistant FDA Individual_Case_Safety_Report_Terminology C53442 Medical Equipment Company Technician or Representative FDA Individual_Case_Safety_Report_Terminology C54027 Medical Problem Patient Problem|Patient Problem Code FDA Individual_Case_Safety_Report_Terminology C53418 Medical Technologist FDA Individual_Case_Safety_Report_Terminology C53523 Mobile Health Unit FDA Individual_Case_Safety_Report_Terminology C53606 Modification or Adjustment FDA Individual_Case_Safety_Report_Terminology C53524 MRI Centers MRI Centers FDA Individual_Case_Safety_Report_Terminology C60812 Multiple Deaths And Serious Injuries FDA Individual_Case_Safety_Report_Terminology C49487 No N FDA Individual_Case_Safety_Report_Terminology C53269 No Information Available No Answer Provided FDA Individual_Case_Safety_Report_Terminology C48660 Not Applicable NA|NOT APPLICABLE FDA Individual_Case_Safety_Report_Terminology C25297 Notification FDA Individual_Case_Safety_Report_Terminology C53419 Nuclear Medicine Technologist FDA Individual_Case_Safety_Report_Terminology C20821 Nurse Nurse FDA Individual_Case_Safety_Report_Terminology C53431 Nursing Assistant FDA Individual_Case_Safety_Report_Terminology C53533 Nursing Home FDA Individual_Case_Safety_Report_Terminology C25193 Occupation FDA Individual_Case_Safety_Report_Terminology C28174 Occupational Therapist occupational therapist FDA Individual_Case_Safety_Report_Terminology C53516 Operating Room FDA Individual_Case_Safety_Report_Terminology C53272 Operator of Medical Device FDA Individual_Case_Safety_Report_Terminology C53618 Original Equipment Manufacturer OEM FDA Individual_Case_Safety_Report_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Individual_Case_Safety_Report_Terminology C53427 Other Caregiver FDA Individual_Case_Safety_Report_Terminology C53289 Other Health Care Professional FDA Individual_Case_Safety_Report_Terminology C53263 Other Personal Medical History FDA Individual_Case_Safety_Report_Terminology C53541 Outdoors FDA Individual_Case_Safety_Report_Terminology C53548 Outpatient Diagnostic Facility FDA Individual_Case_Safety_Report_Terminology C53549 Outpatient Treatment Facility FDA Individual_Case_Safety_Report_Terminology C53420 Paramedic FDA Individual_Case_Safety_Report_Terminology C53542 Park FDA Individual_Case_Safety_Report_Terminology C16960 Patient Lay User/Patient FDA Individual_Case_Safety_Report_Terminology C53432 Patient Family Member Or Friend FDA Individual_Case_Safety_Report_Terminology C53607 Patient Monitoring FDA Individual_Case_Safety_Report_Terminology C60811 Pediatric Death FDA Individual_Case_Safety_Report_Terminology C53578 Periodic FDA Individual_Case_Safety_Report_Terminology C51840 Pharmacist FDA Individual_Case_Safety_Report_Terminology C53421 Phlebotomist FDA Individual_Case_Safety_Report_Terminology C53422 Physical Therapist FDA Individual_Case_Safety_Report_Terminology C25741 Physician FDA Individual_Case_Safety_Report_Terminology C53423 Physician Assistant FDA Individual_Case_Safety_Report_Terminology C53446 Physicist FDA Individual_Case_Safety_Report_Terminology C53689 Playground FDA Individual_Case_Safety_Report_Terminology C53054 Product Problem FDA Individual_Case_Safety_Report_Terminology C53564 Psychiatric Center-Walk in, Other FDA Individual_Case_Safety_Report_Terminology C53536 Psychiatric Facility FDA Individual_Case_Safety_Report_Terminology C53546 Public Building FDA Individual_Case_Safety_Report_Terminology C53688 Public Venue FDA Individual_Case_Safety_Report_Terminology C17049 Race Race FDA Individual_Case_Safety_Report_Terminology C53424 Radiologic Technologist FDA Individual_Case_Safety_Report_Terminology C53517 Radiology Department FDA Individual_Case_Safety_Report_Terminology C53593 Reason for Non-Evaluation FDA 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 Individual_Case_Safety_Report_Terminology C53535 Rehabilitation Center FDA Individual_Case_Safety_Report_Terminology C53608 Relabeling FDA Individual_Case_Safety_Report_Terminology C53611 Repair FDA Individual_Case_Safety_Report_Terminology C53610 Replacement FDA Individual_Case_Safety_Report_Terminology C53566 Report Source FDA Individual_Case_Safety_Report_Terminology C53614 Reprocessor FDA Individual_Case_Safety_Report_Terminology C53425 Respiratory Therapist FDA Individual_Case_Safety_Report_Terminology C53587 Response to FDA Request FDA Individual_Case_Safety_Report_Terminology C53537 Retirement Home FDA Individual_Case_Safety_Report_Terminology C53613 Reuse FDA Individual_Case_Safety_Report_Terminology C53448 Risk Manager FDA Individual_Case_Safety_Report_Terminology C17118 School FDA Individual_Case_Safety_Report_Terminology C53569 Serious Injury FDA Individual_Case_Safety_Report_Terminology C53441 Service and Testing Personnel FDA Individual_Case_Safety_Report_Terminology C53273 Service Personnel FDA Individual_Case_Safety_Report_Terminology C53574 Seven-Day FDA Individual_Case_Safety_Report_Terminology C28421 Sex SEX FDA Individual_Case_Safety_Report_Terminology C53563 Single Use and Reused FDA Individual_Case_Safety_Report_Terminology C28247 Speech Therapist speech therapist FDA Individual_Case_Safety_Report_Terminology C53687 Stationary Imaging Center FDA Individual_Case_Safety_Report_Terminology C25690 Street FDA Individual_Case_Safety_Report_Terminology C53575 Ten-Day FDA Individual_Case_Safety_Report_Terminology C36292 Test Result FDA Individual_Case_Safety_Report_Terminology C53577 Thirty-Day FDA Individual_Case_Safety_Report_Terminology C53525 Tuberculosis Clinic FDA Individual_Case_Safety_Report_Terminology C53265 Type of Device FDA Individual_Case_Safety_Report_Terminology C53053 Type of Event Type of Reportable Event FDA Individual_Case_Safety_Report_Terminology C53584 Type of Follow-Up FDA Individual_Case_Safety_Report_Terminology C54597 Type Of Manufacturer FDA Individual_Case_Safety_Report_Terminology C53603 Type of Remedial Action FDA Individual_Case_Safety_Report_Terminology C53571 Type of Report Report Type FDA Individual_Case_Safety_Report_Terminology C53615 Type of Reporter Reporter Type FDA Individual_Case_Safety_Report_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA Individual_Case_Safety_Report_Terminology C38046 Unspecified FDA Individual_Case_Safety_Report_Terminology C53528 Urgent Care Center FDA Individual_Case_Safety_Report_Terminology C53645 Usage of Device FDA 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 Individual_Case_Safety_Report_Terminology C53552 Ward or Patient Room FDA Individual_Case_Safety_Report_Terminology C25208 Weight WEIGHT FDA Individual_Case_Safety_Report_Terminology C49488 Yes Y|Yes FDA Location_Of_Event_Occurrence_ICSR_Terminology C16281 Ambulatory Care Facility FDA Location_Of_Event_Occurrence_ICSR_Terminology C51957 Ambulatory Surgical Center FDA Location_Of_Event_Occurrence_ICSR_Terminology C51945 Ambulatory Surgical Facility Outpatient Clinic/Surgery FDA Location_Of_Event_Occurrence_ICSR_Terminology C51963 Blood Bank FDA Location_Of_Event_Occurrence_ICSR_Terminology C51964 Bloodmobile FDA Location_Of_Event_Occurrence_ICSR_Terminology C53510 Cardiac Catheterization Suite Catheterization Suite FDA Location_Of_Event_Occurrence_ICSR_Terminology C51967 Chemotherapy Center FDA Location_Of_Event_Occurrence_ICSR_Terminology C51282 Clinic - Walk in, Other FDA Location_Of_Event_Occurrence_ICSR_Terminology C53518 Dialysis Center FDA Location_Of_Event_Occurrence_ICSR_Terminology C53512 Dialysis Unit FDA Location_Of_Event_Occurrence_ICSR_Terminology C53519 Drug Clinic FDA Location_Of_Event_Occurrence_ICSR_Terminology C53513 Emergency Room FDA Location_Of_Event_Occurrence_ICSR_Terminology C53514 Examination Room FDA Location_Of_Event_Occurrence_ICSR_Terminology C51966 Free-Standing Cardiac Catheterization Laboratory FDA Location_Of_Event_Occurrence_ICSR_Terminology C18002 Home FDA Location_Of_Event_Occurrence_ICSR_Terminology C53532 Hospice FDA Location_Of_Event_Occurrence_ICSR_Terminology C16696 Hospital FDA Location_Of_Event_Occurrence_ICSR_Terminology C53521 Imaging Center - Mobile FDA Location_Of_Event_Occurrence_ICSR_Terminology C53538 In Transit to User/Medical Facility FDA Location_Of_Event_Occurrence_ICSR_Terminology C53511 Intensive Care Unit Critical Care Unit FDA Location_Of_Event_Occurrence_ICSR_Terminology C50913 Invalid Data FDA Location_Of_Event_Occurrence_ICSR_Terminology C37984 Laboratory FDA Location_Of_Event_Occurrence_ICSR_Terminology C53551 Laboratory or Pathology Department FDA Location_Of_Event_Occurrence_ICSR_Terminology C53509 Location Where Event Occurred FDA Location_Of_Event_Occurrence_ICSR_Terminology C53530 Long-Term Care Facility FDA Location_Of_Event_Occurrence_ICSR_Terminology C53515 Maternity Ward - Nursery FDA Location_Of_Event_Occurrence_ICSR_Terminology C53523 Mobile Health Unit FDA Location_Of_Event_Occurrence_ICSR_Terminology C53524 MRI Centers MRI Centers FDA Location_Of_Event_Occurrence_ICSR_Terminology C53269 No Information Available No Answer Provided FDA Location_Of_Event_Occurrence_ICSR_Terminology C48660 Not Applicable NA|NOT APPLICABLE FDA Location_Of_Event_Occurrence_ICSR_Terminology C53533 Nursing Home FDA Location_Of_Event_Occurrence_ICSR_Terminology C53516 Operating Room FDA Location_Of_Event_Occurrence_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Location_Of_Event_Occurrence_ICSR_Terminology C53541 Outdoors FDA Location_Of_Event_Occurrence_ICSR_Terminology C53548 Outpatient Diagnostic Facility FDA Location_Of_Event_Occurrence_ICSR_Terminology C53549 Outpatient Treatment Facility FDA Location_Of_Event_Occurrence_ICSR_Terminology C53542 Park FDA Location_Of_Event_Occurrence_ICSR_Terminology C53689 Playground FDA Location_Of_Event_Occurrence_ICSR_Terminology C53564 Psychiatric Center-Walk in, Other FDA Location_Of_Event_Occurrence_ICSR_Terminology C53536 Psychiatric Facility FDA Location_Of_Event_Occurrence_ICSR_Terminology C53546 Public Building FDA Location_Of_Event_Occurrence_ICSR_Terminology C53688 Public Venue FDA Location_Of_Event_Occurrence_ICSR_Terminology C53517 Radiology Department FDA Location_Of_Event_Occurrence_ICSR_Terminology C53535 Rehabilitation Center FDA Location_Of_Event_Occurrence_ICSR_Terminology C53537 Retirement Home FDA Location_Of_Event_Occurrence_ICSR_Terminology C17118 School FDA Location_Of_Event_Occurrence_ICSR_Terminology C53687 Stationary Imaging Center FDA Location_Of_Event_Occurrence_ICSR_Terminology C25690 Street FDA Location_Of_Event_Occurrence_ICSR_Terminology C53525 Tuberculosis Clinic FDA Location_Of_Event_Occurrence_ICSR_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA Location_Of_Event_Occurrence_ICSR_Terminology C53528 Urgent Care Center FDA Location_Of_Event_Occurrence_ICSR_Terminology C53552 Ward or Patient Room FDA Occupation_ICSR_Terminology C51959 Attorney FDA Occupation_ICSR_Terminology C51804 Audiologist FDA Occupation_ICSR_Terminology C51960 Biomedical Engineer FDA Occupation_ICSR_Terminology C53428 Dental Assistant FDA Occupation_ICSR_Terminology C53293 Dental Hygienist FDA Occupation_ICSR_Terminology C52654 Dentist FDA Occupation_ICSR_Terminology C28248 Dietician dietitian FDA Occupation_ICSR_Terminology C53417 Emergency Medical Technician FDA Occupation_ICSR_Terminology C53287 Health Care Professional FDA Occupation_ICSR_Terminology C53429 Home Health Aid FDA Occupation_ICSR_Terminology C53433 Hospital Service Technician FDA Occupation_ICSR_Terminology C50913 Invalid Data FDA Occupation_ICSR_Terminology C53430 Medical Assistant FDA Occupation_ICSR_Terminology C53442 Medical Equipment Company Technician or Representative FDA Occupation_ICSR_Terminology C53418 Medical Technologist FDA Occupation_ICSR_Terminology C53269 No Information Available No Answer Provided FDA Occupation_ICSR_Terminology C48660 Not Applicable NA|NOT APPLICABLE FDA Occupation_ICSR_Terminology C53419 Nuclear Medicine Technologist FDA Occupation_ICSR_Terminology C20821 Nurse Nurse FDA Occupation_ICSR_Terminology C53431 Nursing Assistant FDA Occupation_ICSR_Terminology C25193 Occupation FDA Occupation_ICSR_Terminology C28174 Occupational Therapist occupational therapist FDA Occupation_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Occupation_ICSR_Terminology C53427 Other Caregiver FDA Occupation_ICSR_Terminology C53289 Other Health Care Professional FDA Occupation_ICSR_Terminology C53420 Paramedic FDA Occupation_ICSR_Terminology C51840 Pharmacist FDA Occupation_ICSR_Terminology C53421 Phlebotomist FDA Occupation_ICSR_Terminology C53422 Physical Therapist FDA Occupation_ICSR_Terminology C25741 Physician FDA Occupation_ICSR_Terminology C53423 Physician Assistant FDA Occupation_ICSR_Terminology C53446 Physicist FDA Occupation_ICSR_Terminology C53424 Radiologic Technologist FDA Occupation_ICSR_Terminology C53425 Respiratory Therapist FDA Occupation_ICSR_Terminology C53448 Risk Manager FDA Occupation_ICSR_Terminology C53441 Service and Testing Personnel FDA Occupation_ICSR_Terminology C53273 Service Personnel FDA Occupation_ICSR_Terminology C28247 Speech Therapist speech therapist FDA Occupation_ICSR_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA Operator_of_Medical_Device_ICSR_Terminology C51804 Audiologist FDA Operator_of_Medical_Device_ICSR_Terminology C51960 Biomedical Engineer FDA Operator_of_Medical_Device_ICSR_Terminology C53428 Dental Assistant FDA Operator_of_Medical_Device_ICSR_Terminology C53293 Dental Hygienist FDA Operator_of_Medical_Device_ICSR_Terminology C52654 Dentist FDA Operator_of_Medical_Device_ICSR_Terminology C53274 Device Unattended FDA Operator_of_Medical_Device_ICSR_Terminology C28248 Dietician dietitian FDA Operator_of_Medical_Device_ICSR_Terminology C53417 Emergency Medical Technician FDA Operator_of_Medical_Device_ICSR_Terminology C53287 Health Care Professional FDA Operator_of_Medical_Device_ICSR_Terminology C53429 Home Health Aid FDA Operator_of_Medical_Device_ICSR_Terminology C53433 Hospital Service Technician FDA Operator_of_Medical_Device_ICSR_Terminology C50913 Invalid Data FDA Operator_of_Medical_Device_ICSR_Terminology C53430 Medical Assistant FDA Operator_of_Medical_Device_ICSR_Terminology C53442 Medical Equipment Company Technician or Representative FDA Operator_of_Medical_Device_ICSR_Terminology C53418 Medical Technologist FDA Operator_of_Medical_Device_ICSR_Terminology C53269 No Information Available No Answer Provided FDA Operator_of_Medical_Device_ICSR_Terminology C48660 Not Applicable NA|NOT APPLICABLE FDA Operator_of_Medical_Device_ICSR_Terminology C53419 Nuclear Medicine Technologist FDA Operator_of_Medical_Device_ICSR_Terminology C20821 Nurse Nurse FDA Operator_of_Medical_Device_ICSR_Terminology C53431 Nursing Assistant FDA Operator_of_Medical_Device_ICSR_Terminology C28174 Occupational Therapist occupational therapist FDA Operator_of_Medical_Device_ICSR_Terminology C53272 Operator of Medical Device FDA Operator_of_Medical_Device_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Operator_of_Medical_Device_ICSR_Terminology C53427 Other Caregiver FDA Operator_of_Medical_Device_ICSR_Terminology C53289 Other Health Care Professional FDA Operator_of_Medical_Device_ICSR_Terminology C53420 Paramedic FDA Operator_of_Medical_Device_ICSR_Terminology C16960 Patient Lay User/Patient FDA Operator_of_Medical_Device_ICSR_Terminology C53432 Patient Family Member Or Friend FDA Operator_of_Medical_Device_ICSR_Terminology C51840 Pharmacist FDA Operator_of_Medical_Device_ICSR_Terminology C53421 Phlebotomist FDA Operator_of_Medical_Device_ICSR_Terminology C53422 Physical Therapist FDA Operator_of_Medical_Device_ICSR_Terminology C25741 Physician FDA Operator_of_Medical_Device_ICSR_Terminology C53423 Physician Assistant FDA Operator_of_Medical_Device_ICSR_Terminology C53446 Physicist FDA Operator_of_Medical_Device_ICSR_Terminology C53424 Radiologic Technologist FDA Operator_of_Medical_Device_ICSR_Terminology C53425 Respiratory Therapist FDA Operator_of_Medical_Device_ICSR_Terminology C53448 Risk Manager FDA Operator_of_Medical_Device_ICSR_Terminology C53441 Service and Testing Personnel FDA Operator_of_Medical_Device_ICSR_Terminology C53273 Service Personnel FDA Operator_of_Medical_Device_ICSR_Terminology C28247 Speech Therapist speech therapist FDA Operator_of_Medical_Device_ICSR_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA Reason_For_Non-Evaluation_ICSR_Terminology C53601 Device Evaluation Anticipated But Not Yet Begun FDA Reason_For_Non-Evaluation_ICSR_Terminology C53599 Device Not Made by Company FDA Reason_For_Non-Evaluation_ICSR_Terminology C53600 Device Problem Already Known No Evaluation Necessary FDA Reason_For_Non-Evaluation_ICSR_Terminology C53598 Device Received in Condition Which Made Analysis Impossible FDA Reason_For_Non-Evaluation_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Reason_For_Non-Evaluation_ICSR_Terminology C53593 Reason for Non-Evaluation FDA Report_Source_ICSR_Terminology C15206 Clinical Study clinical study FDA Report_Source_ICSR_Terminology C51968 Company Representative FDA Report_Source_ICSR_Terminology C53568 Consumer FDA Report_Source_ICSR_Terminology C48289 Distributor FDA Report_Source_ICSR_Terminology C25512 Foreign FDA Report_Source_ICSR_Terminology C53287 Health Care Professional FDA Report_Source_ICSR_Terminology C50913 Invalid Data FDA Report_Source_ICSR_Terminology C48471 Literature FDA Report_Source_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Report_Source_ICSR_Terminology C53566 Report Source FDA Report_Source_ICSR_Terminology C17998 Unknown U|UNKNOWN|Unknown (For Use When The Patients Condition Is Not Known) FDA 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 Type_of_Event_ICSR_Terminology C41331 Adverse Event ADVERSE EVENT FDA Type_of_Event_ICSR_Terminology C53054 Product Problem FDA Type_of_Event_ICSR_Terminology C53053 Type of Event Type of Reportable Event FDA Type_Of_Follow-Up_ICSR_Terminology C53586 Additional Information FDA Type_Of_Follow-Up_ICSR_Terminology C53585 Correction FDA Type_Of_Follow-Up_ICSR_Terminology C53588 Device Evaluation FDA Type_Of_Follow-Up_ICSR_Terminology C53587 Response to FDA Request FDA Type_Of_Follow-Up_ICSR_Terminology C53584 Type of Follow-Up FDA Type_Of_Manufacturer_ICSR_Terminology C53618 Original Equipment Manufacturer OEM FDA Type_Of_Manufacturer_ICSR_Terminology C53614 Reprocessor FDA Type_Of_Manufacturer_ICSR_Terminology C54597 Type Of Manufacturer FDA Type_Of_Remedial_Action_ICSR_Terminology C53604 Inspection FDA Type_Of_Remedial_Action_ICSR_Terminology C50913 Invalid Data FDA Type_Of_Remedial_Action_ICSR_Terminology C53606 Modification or Adjustment FDA Type_Of_Remedial_Action_ICSR_Terminology C53269 No Information Available No Answer Provided FDA Type_Of_Remedial_Action_ICSR_Terminology C25297 Notification FDA Type_Of_Remedial_Action_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Type_Of_Remedial_Action_ICSR_Terminology C53607 Patient Monitoring FDA 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 Type_Of_Remedial_Action_ICSR_Terminology C53608 Relabeling FDA Type_Of_Remedial_Action_ICSR_Terminology C53611 Repair FDA Type_Of_Remedial_Action_ICSR_Terminology C53610 Replacement FDA Type_Of_Remedial_Action_ICSR_Terminology C53603 Type of Remedial Action FDA Type_Of_Report_ICSR_Terminology C53580 FDA Requested FDA Type_Of_Report_ICSR_Terminology C53576 Fifteen-Day FDA Type_Of_Report_ICSR_Terminology C53573 Five-Day FDA Type_Of_Report_ICSR_Terminology C53579 Follow-Up FDA Type_Of_Report_ICSR_Terminology C53620 Initial FDA Type_Of_Report_ICSR_Terminology C53581 Manufacturer Response to Voluntary Report FDA Type_Of_Report_ICSR_Terminology C53578 Periodic FDA Type_Of_Report_ICSR_Terminology C53574 Seven-Day FDA Type_Of_Report_ICSR_Terminology C53575 Ten-Day FDA Type_Of_Report_ICSR_Terminology C53577 Thirty-Day FDA Type_Of_Report_ICSR_Terminology C53571 Type of Report Report Type FDA Type_of_Reportable_Event_ICSR_Terminology C28554 Death DEATH FDA Type_of_Reportable_Event_ICSR_Terminology C25745 Failure FDA Type_of_Reportable_Event_ICSR_Terminology C60812 Multiple Deaths And Serious Injuries FDA Type_of_Reportable_Event_ICSR_Terminology C17649 Other OTHER|Other|Other (For Use When An Appropriate Patient Code Cannot Be Identified)|Other FDA Type_of_Reportable_Event_ICSR_Terminology C60811 Pediatric Death FDA Type_of_Reportable_Event_ICSR_Terminology C53569 Serious Injury FDA Type_of_Reportable_Event_ICSR_Terminology C53053 Type of Event Type of Reportable Event FDA 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 Type_Of_Reporter_ICSR_Terminology C53616 Manufacturer FDA Type_Of_Reporter_ICSR_Terminology C53615 Type of Reporter Reporter Type FDA 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.