BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORIGIN TACKER

    MDR report key: 270847 · Received March 23, 2000

    Report

    Report Number
    MW1018477
    Event Type
    Other
    Date Received
    March 23, 2000
    Date of Event
    December 1, 1999
    Report Date
    March 23, 2000
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD HERNIA REPAIR USING THESE CLIPS. AFTERWARDS RPTR'S WHOLE BODY STARTED TINGLING AND RPTR DEVELOPED FLU-LIKE SYMPTOMS. THEY ALSO EXPERIENCED EXTREME FATIGUE AND PAIN. DR FELT RPTR SHOULDN'T BE IN SUCH PAIN. DR INJECTED CORTISONE WHICH DID NOT HELP. AN ORTHOPEDIC SURGEON COMMENTED THAT RPTR HAD A LOT OF CLIPS IN BUT THAT NO ONE WAS ALLERGIC TO THESE DEVICES. RPTR IS GOING TO SEE A DERMATOLOGIST FOR ALLERGY TESTING TO DETERMINE IF THEY ARE ALLERGIC AND NEED TO HAVE THE CLIPS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGIN TACKER TITANIUM CLIP FZP ORIGIN MEDSYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other