BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAD

    MDR report key: 2132604 · Received June 11, 2011

    Report

    Report Number
    MW5020988
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 11, 2011
    Manufacturer
    MEDLINE INDUSTRIES
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OPENED A CURAD FLEXIBLE ATHLETIC STRIP BOX TO USE ON MY CARPAL TUNNEL SURGERY STITCHES AND FOUND THAT THE ABSORBENT NON-STICK PAD WAS OFF CENTER AND A HOLE IN THE STRIP AT ONE SIDE. ON FURTHER INSPECTION, A PIECE OF METAL WAS FOUND IN THE HOLE. HAD I NOT BEEN PAYING ATTENTION, THIS COULD HAVE BEEN PLACED ON MY STITCHES AND POSSIBLY CAUSED SERIOUS PROBLEMS. THE LOT NUMBER OF THE PRODUCT IS 110A019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURAD FLEXIBLE XL ATHLETIC STRIP KGX MEDLINE INDUSTRIES 110A019

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR