Transcription of MEDWATCH for MANDATORY reporting
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MEDWATCH for MANDATORY reporting
Dateof Birth:A. PATIENT INFORMATIONFDA Use OnlyForm Approved: OMB No. 0910-0291, Expires: 6/30/2015 See OMB statement on FDA 3500A (2/13)E. INITIAL Attributed to Adverse Event(Check all that apply)Adverse Eventand/orProduct Problem( , defects/malfunctions) of Event(mm/dd/yyyy) of This Report(mm/dd/yyyy) 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(mm/dd/yyyy)For use by user-facilities,importers, distributors and manufacturersfor MANDATORY reportingB. ADVERSE EVENT OR PRODUCT Device of Implanted, Give Date(mm/dd/yyyy) Available for Evaluation?(Do not send to FDA) Explanted, Give Date(mm/dd/yyyy) Name, City and # and Medical Products and Therapy Dates(Exclude treatment of event)D.
Date of Birth: A. PATIENT INFORMATION FDA Use Only Form Approved: OMB No. 0910-0291, Expires: 6/30/2015 See OMB statement on reverse. FORM FDA 3500A (2/13)
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