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Warning Text %XTableStyleMedium9PivotStyleLight16`Y11.12e!  ;ZR3 A@@   r Source Subset Code Subset Name Concept Code Source PTSource DefinitionSource Synonym(s)FDAC54447)Individual Case Safety Report TerminologyC25274ACTUALC53586ADDITIONAL INFORMATIONC49489ADVERSE EVENT OUTCOME#OUTCOME ATTRIBUTED TO ADVERSE EVENTC88073ADVERSE EVENT EXPOSURE CODEC41331 ADVERSE EVENTC88082ADVERSE EVENT TREATMENTC88065AGE AT TIME OF ADVERSE EVENTC25150AGEC51957AMBULATORY SURGICAL CENTERC16281AMBULATORY CARE FACILITYC51945AMBULATORY SURGICAL FACILITYOUTPATIENT CLINIC/SURGERYC14182ANIMALC94850 ENCLOSUREC53451APPROXIMATE AGE OF DEVICEC51959ATTORNEYC51804 AUDIOLOGISTC51960BIOMEDICAL ENGINEERC51964 BLOODMOBILEC53692BREEDC51963 BLOOD BANKC53510CARDIAC CATHETERIZATION SUITECATHETERIZATION SUITEC51967CHEMOTHERAPY CENTERC15206CLINICAL STUDYC51282CLINIC - WALK IN, OTHERC51968COMPANY REPRESENTATIVEC54696Combination Product(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; (2) Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; (3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose; or (4) Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect.C88066CROSSBREED INDICATORC53630Concomitant TherapyC93539-Reporter Confidentiality Disclosure IndicatorjAn indicator of whether the reporter does or does not want his/her identity disclosed to the manufacturer.C2849CONGENITAL DEFECT/DEFORMITYDEFECT/DEFORMITY, CONGENITALC53585 CORRECTIONC25464COUNTRYC53568CONSUMER/CONCERNED CITIZENC53619CORRECTIVE ACTION NUMBERC28554DIED EXPIRED/DEATHC53481%DATE OF DEVICE RETURN TO MANUFACTURERC53486DATE OF CONCOMITANT THERAPYC53428DENTAL ASSISTANTC54026DEVICE PROBLEMC53588DEVICE EVALUATIONC54028EVALUATION METHODC53449DEVICE AVAILABLE FOR EVALUATIONC53602DEVICE LABELED FOR SINGLE USEC54030EVALUATION CONCLUSIONC53601/DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUNC53599DEVICE NOT MADE BY COMPANYC53629 Device Evaluated by ManufacturerC54029EVALUATION RESULTC52654DENTISTC53293DENTAL HYGIENISTC536004DEVICE PROBLEM ALREADY KNOWN NO EVALUATION NECESSARYC28248 DIETICIANC53645USAGE OF DEVICEC53591.DEVICE RETURNED TO MANUFACTURER FOR EVALUATIONC53512 DIALYSIS UNITC53274DEVICE UNATTENDEDC53598;DEVICE RECEIVED IN CONDITION WHICH MADE ANALYSIS IMPOSSIBLEC21007 DISABILITYC53518DIALYSIS CENTERC48289 DISTRIBUTORC53519 DRUG CLINICC53513EMERGENCY ROOMC53417EMERGENCY MEDICAL TECHNICIANC25498 ESTIMATEDC53592EVALUATION SUMMARY STATUSC53514EXAMINATION ROOMC92487EXPLANATION OF OFF LABEL USEC53580 FDA REQUESTEDC16576FEMALEC25745FAILUREC53573FIVE-DAYC53576 FIFTEEN-DAYC25512FOREIGNC53579 FOLLOW-UPC17237Food and Drug AdministrationC519660FREE-STANDING CARDIAC CATHETERIZATION LABORATORYC88078OFOOD AND DRUG ADMINISTRATION OFFICE OF REGULATORY AFFAIRS DISTRICT FIELD OFFICEC88072(GESTATIONAL AGE AT TIME OF ADVERSE EVENTC88067#HEALTH ASSESSMENT PRIOR TO EXPOSUREC53287HEALTH CARE PROFESSIONALC53429HOME HEALTH AIDC18002HOMEC16696HOSPITALC50414HOSPITALIZATION REQUIREDC88086+ICSR ASSIGNED ENTITY ORGANIZATION ROLE CODEC88085%ICSR ASSIGNED ENTITY PERSON ROLE CODEC53433HOSPITAL SERVICE TECHNICIANC53532HOSPICEC25179HOSPITALIZATIONC53617IMPORTERAny 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.C53538#IN TRANSIT TO USER/MEDICAL FACILITYC53604 INSPECTIONC53620INITIALC53511INTENSIVE CARE UNITCRITICAL CARE UNITC53612C52668INTERVENTION REQUIREDC50913 INVALID DATAC37984 LABORATORYC53551"LABORATORY OR PATHOLOGY DEPARTMENTC41337LIFE THREATENINGLife Threatening Adverse EventC92489JLENGTH OF TIME BETWEEN PRODUCT EXPOSURE AND ONSET OF ADVERSE EVENT SYMPTOMC53509LOCATION WHERE EVENT OCCURREDC53530LONG-TERM CARE FACILITYC20197MALEC53524 MRI CENTER MRI CENTERSC53581)MANUFACTURER RESPONSE TO VOLUNTARY REPORTC53515MATERNITY WARD - NURSERYC25392 MANUFACTURERManufacturer means any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure.C88074MARKETING AUTHORIZATION HOLDERC534426MEDICAL EQUIPMENT COMPANY TECHNICIAN OR REPRESENTATIVEC53430MEDICAL ASSISTANTC53418MEDICAL TECHNOLOGISTC53606MODIFICATION OR ADJUSTMENTC53521IMAGING CENTER - MOBILEC53523MOBILE HEALTH UNITC60812$MULTIPLE DEATHS AND SERIOUS INJURIESC88071NEGATIVE RECHALLENGE INDICATORC25297 NOTIFICATIONC53419NUCLEAR MEDICINE TECHNOLOGISTC48660NOT APPLICABLEC88076NUMBER OF DEFECTIVE UNITSC53269NO INFORMATIONNO ANSWER PROVIDEDC49487NOC88077NUMBER OF UNITS RETURNEDC88075NUMBER OF ANIMALS AFFECTEDC53431NURSING ASSISTANTC20821NURSEC25193 OCCUPATIONC28174OCCUPATIONAL THERAPISTC53516OPERATING ROOMC53533 NURSING HOMEC53272OPERATOR OF MEDICAL DEVICEC17649OTHEROtherC53263OTHER PERSONAL MEDICAL HISTORYC53548OUTPATIENT DIAGNOSTIC FACILITYC53618ORIGINAL EQUIPMENT MANUFACTURERC53427OTHER CAREGIVERC53541OUTDOORSC54068Over-the-Counter Product@A product that is available to consumers without a prescription.C53549OUTPATIENT TREATMENT FACILITYC53289OTHER HEALTH CARE PROFESSIONALC60811PEDIATRIC DEATHC54027PATIENT PROBLEMPATIENT PROBLEM CODEC53542PARKC16960PATIENTLAY USER/PATIENTC53432PATIENT FAMILY MEMBER OR FRIENDC53420 PARAMEDICC53607PATIENT MONITORINGC51840 PHARMACISTC53578PERIODICC25741 PHYSICIANC53421 PHLEBOTOMISTC53423PHYSICIAN ASSISTANTC53446 PHYSICISTC53689 PLAYGROUNDC53422PHYSICAL THERAPISTC99176Pre-1938 ProductxA drug product that was on the market prior to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (the FD&C Act) and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act, was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application.C88070POSITIVE RECHALLENGE INDICATORC88069'POSITIVE DECHALLENGE REACTION INDICATORC88087PRIMARY SOURCE REPORTERC88079 PREVIOUS ADVERSE EVENT INDICATORC95017FEMALE PHYSIOLOGICAL STATUSBA description of the pregnancy and lactation status of the a< nimal.C88080PREVIOUS EXPOSURE INDICATORC53054PRODUCT PROBLEMC53564!PSYCHIATRIC CENTER-WALK IN, OTHERC48471 LITERATUREC53688 PUBLIC VENUEC94848QUANTITY EXACTNESSC53546PUBLIC BUILDINGC94851QUARTERC53536PSYCHIATRIC FACILITYC53517RADIOLOGY DEPARTMENTC17049RACEC53424RADIOLOGIC TECHNOLOGISTC53609RECALL*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.C53593REASON FOR NON-EVALUATIONC53613REUSEC53610 REPLACEMENTC53611REPAIRC53425RESPIRATORY THERAPISTC88081REGULATORY AUTHORITYC53537RETIREMENT HOMEC53566 REPORT SOURCEC53587RESPONSE TO FDA REQUESTC53614 REPROCESSORC53535REHABILITATION CENTERC53608 RELABELINGC53448 RISK MANAGERC17118SCHOOLC53273SERVICE PERSONNELC53441SERVICE AND TESTING PERSONNELC28421SEXC53563SINGLE USE AND REUSEDC53574 SEVEN-DAYC53569SERIOUS INJURYC19177SPEECH THERAPISTC53687STATIONARY IMAGING CENTERC25690STREETC77664TEATC36292 TEST RESULTC53575TEN-DAYC53577 THIRTY-DAYC53525TUBERCULOSIS CLINICC53571TYPE OF REPORT REPORT TYPEC53603TYPE OF REMEDIAL ACTIONC54597TYPE OF MANUFACTURERC17998UNKNOWNUnknownC38046 UNSPECIFIEDC53265TYPE OF DEVICEC53053 TYPE OF EVENTTYPE OF REPORTABLE EVENTC53615TYPE OF REPORTER REPORTER TYPEC88083TYPE OF REPORT INFORMATIONC53528URGENT CARE CENTERC53584TYPE OF FOLLOW-UPC88084!USED ACCORDING TO LABEL INDICATORC53567 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.C25208WEIGHTC53552WARD OR PATIENT ROOMC88068CVETERINARY ANATOMIC THERAPEUTIC CHEMICAL CLASSIFICATION SYSTEM CODEC49488YESC54580Type of Event ICSR TerminologyC54583&Adverse Event Outcome ICSR TerminologyC54584+Operator of Medical Device ICSR TerminologyC54585Occupation ICSR TerminologyC54587Report Source ICSR TerminologyC54588Type of Report ICSR TerminologyC54590-Location of Event Occurrence ICSR TerminologyC54591)Type of Reportable Event ICSR TerminologyC54592"Type of Follow-Up ICSR TerminologyC54593*Reason for Non-Evaluation ICSR TerminologyC54594(Type of Remedial Action ICSR TerminologyC54595Device Usage ICSR TerminologyC54596!Type of Reporter ICSR TerminologyC54598%Type of Manufacturer ICSR TerminologyC88088Observation ICSR TerminologyC94849+Dose Denominator Qualifier ICSR TerminologyC99173"Device Evaluation ICSR TerminologyC99174'Product Characteristic ICSR TerminologyC99175)Substance Administration ICSR Terminology * +z+1,,&-- .j.3B 4C X5 5E t6 "7 7 18 8%699:em:g;;)}<>?vx?Y@@AUB6CC DDEcE2FF(3GGGPI<JHKKLMM NFyNNPOO PGrPPZQQ#|S6Tq T$ U vV 6Wq ccB  L[ivf vX . .v%  dMbP?_*+%&?'?(?)?"d,,??&U} I } } I } m} I  Subset Namet*t @@@@@@@@@ @ @ @ @ @@@@@@@@@@@@@@@@@@@ ? ? ? ? ? ? ?   > # >$ >   > : >; >   >  > >   >  > >   >  > >   > : >; > ><   > u >v >   >  > >   >  > >   >  >  > >!   >  > > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   >  > >   > O >P >   >  > >   >  > >   >  > >   > G >H >   >  > >   >  > >   > x >y > D8 lbTTTTTbTTTbbTTTTTTTTTTTTTTTTTTT @!@"@#@$@%@&@'@(@)@*@+@,@-@.@/@0@1@2@3@4@5@6@7@8@9@:@;@<@=@>@?@   >  > > ! ! !> !J !>K !> !>L " " "> "U ">V "> ">W # # #> # #> #> $ $ $> $ $> $> % % %> % %> %> & & &> & &> &> ' ' '> ' '> '> '> ( ( (> ( (> (> ) ) )> )g )>h )> * * *> * *> *> + + +> +  +>  +> , , ,> , ,> ,> - - -> - -> -> -> . . .> . .> .> / / /> / /> /> 0 0 0> 0< 0>= 0> 1 1 1> 1+ 1>, 1> 2 2 2> 2C 2>D 2> 3 3 3> 3 3>! 3> 3>" 4 4 4> 4 4> 4> 5 5 5> 5) 5>* 5> 6 6 6> 6- 6>. 6> 7 7 7> 73 7>4 7> 8 8 8> 8/ 8>0 8> 9 9 9> 9 9> 9> : : :> :8 :>9 :> ; ; ;> ;> ;>? ;> < < <> <r <>s <> = = => = => => > > >> > >> >> >> ? ? ?> ?c ?>d ?> DT lTbbTTTTbTTTTTbTTTTTbTTTTTTTTTTb@@A@B@C@D@E@F@G@H@I@J@K@L@M@N@O@P@Q@R@S@T@U@V@W@X@Y@Z@[@\@]@^@_@ @ @ @> @" @># @> A A A> A A> A> B B B> B B>  B> B>  C C C> C C> C> D D D> D D> D> E E E> E E> E> F F F> F F> F> G G G> G1 G>2 G> H H H> Ht H>u H> I I I> I I> I> J J J> J J> J> K K K> K K> K> L L L> L? 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