MEDWATCH - Premier Safety Institute

1 The FDA Safety Information andAdverse Event Reporting ProgramDateof Birth:Page ____ of ____A. PATIENT INFORMATIONFDA Use OnlyForm Approved: OMB No. 0910-0291, Expires: 03/31/05 See OMB statement on FDA 3500A (9/03)Other:E. INITIAL REPORTERH ospitalization - initial or Intervention to PreventPermanent Impairment/DamageLife-threatening(mo/day /yr)Congenital Attributed to Adverse Event(Check all that apply)Adverse Eventand/orProduct Problem( , defects/malfunctions) of Event(mo/day/year) of This Report(mo/day/year) Event or Tests/Laboratory Data, Including Relevant History, Including Preexisting Medical Conditions( , allergies,race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)Expiration Date(mo/day/yr)For use by user-facilities,importers, distributors and manufacturersfor MANDATORY reportingB. ADVERSE EVENT OR PRODUCT of of Implanted, Give Date(mo/day/yr) Available for Evaluation?(Do not send to FDA) Explanted, Give Date(mo/day/yr) Name, City and # and Medical Products and Therapy Dates(Exclude treatment of event)D.

2 SUSPECT MEDICAL DEVICENoReturned to Manufacturer Professional?Phone # Reporter Also SentReport to Department of Health and Human ServicesIn at Timeof IdentifierMaleOther #Serial # Yes to Item No. 8, Enter Name and Address of ReprocessorCatalog #Lot #Other:YesDisabilityor(mo/day/yr)PLEASE TYPE OR USE BLACK INKMfr Report #Submission of a report does not constitutean admission that medical personnel, userfacility, importer, distributor, manufacturer orproduct caused or contributed to the ProfessionalLay User/PatientUF/Importer Report # this a Single-use Device that was Reprocessed and Reused on a Patient?C. SUSPECT MEDICATION(S) (Give labeled strength & mfr/labeler, if known)# , Frequency & Route Used#2#1#2#1# Dates(If unknown, give duration)from/to (or best estimate) for Use(Indication)#1# #(if known)# #(For product problems only ) Medical Products and Therapy Dates(Exclude treatment of event)# Date(if known)#1#2 YesYesNo#1 Doesn' Reappeared AfterReintroduction?

3 YesNoNo#1#2 Doesn'tApplyDoesn' Abated After UseStopped or Dose Reduced?YesNo#2 Doesn' Manufacturer Dataand / orPage ____ of ____F. FOR USE BY USER FACILITY/IMPORTER(Devices only )FDA USE ONLYH. DEVICE MANUFACTURERS ONLYD epartment of Health and Human ServicesFood and Drug AdministrationMedWatch; HFD-4105600 Fishers LaneRockville, MD 20857 FORM FDA 3500A (9/03) (Back)G. ALL MANUFACTURERSP ublic Health ServiceFood and Drug DEPARTMENT OF HEALTH AND HUMAN SERVICESM edication and DeviceExperience Report(Continued)Refer to guidelines for specific of a report does not constitutean admission that medical personnel, userfacility, importer, distributor, manufacturer orproduct caused or contributed to the Facility or Importer Report NumberUser User Facility orImporter BecameAware of Event(mo/day/yr)(Specify) of of Problem Codes(Refer to coding manual) Sent to FDA? of This Report(mo/day/yr) Where Event Sent to Manufacturer?

4 OutpatientDiagnostic FacilityOutpatient TreatmentFacilityConclusionsNursing HomeFollow-up #Yes(mo/day/yr)YesInitialOther:Health Professional(A)NDA #No(mo/day/yr)YesEvaluation Summary Office - Name/Address(and Manufacturing Sitefor Devices) Event Term(s) Source(Check all that apply)PLA # IND, Give Protocol # of Report(Check all that apply) Received byManufacturer(mo/day/yr) # Report NumberYesForeignStudy5-dayModification/A djustmentConsumerInitialOTCP roduct10-dayUser FacilityDistributorOther:PeriodicIND #The public reporting burden for this collection of information has been estimated to average onehour per response, including the time for reviewing instructions, searching existing datasources, gathering and maintaining the data needed, and completing and reviewing thecollection of information. Send comments regarding this burden estimate or any other aspect ofthis collection of information, including suggestions for reducing this burden to:Please DO NOT RETURN this form to this Statement:"An agency may not conduct or sponsor,and a person is not required to respondto, a collection of information unless itdisplays a currently valid OMB controlnumber.

5 " of Reportable Follow-up, What Type?AmbulatorySurgical Evaluated by Manufacturer? Manufacture Date(mo/yr) for Single Use?No(Attach page to explain why not)orprovide Codes(Refer to coding manual) Remedial Action Initiated, Check TypeIf action reported to FDA under21 USC 360i(f), list correction/removal reporting of DeviceOther:.YesDeathHospitalNotificatio nInspectionPatient MonitoringResultsYesNot Returned to ManufacturerSerious InjuryMalfunctionRelabelingCorrectionAdd itional InformationResponse to FDA RequestDevice EvaluationInitial Use of DeviceReuseUnknownOther:RecallRepairRepl ac