BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTY SPLINT

    MDR report key: 939379 · Received November 5, 2007

    Report

    Report Number
    MW5004337
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 5, 2007
    Manufacturer
    APOTHECARY PROCUCTS, INC.
    Product Code
    FYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A 2-SIDED FINGER SPLINT. IT WAS MANUFACTURED IN ANOTHER COUNTRY AND SOLD THROUGH APOTHECARY PRODUCTS. IT CAME IN A BOX WITH TWO SPLINTS. THE SPLINT WITH ONE HOOK AND LOOP BAND DIDN'T WORK TOO BAD. BUT I HAVE BEEN USING THE ONE WITH 2 HOOK AND LOOP BANDS AND THE BANDS WILL NOT PULL TIGHT. I AM WALKING AROUND WITH A SPLINT WITH BANDS HANGING DOWN NOT FASTENED BECAUSE THEY WON'T STAY FASTENED. THEY ADVERTISE THIS TO USE ON A WOUND AFTER YOU HAVE THE BLEEDING STOPPED. YOU CAN NOT GET ENOUGH PRESSURE WITH THIS DUE TO THE BAND SITUATION TO HELP STOP A WOUND FROM BLEEDING LIKE THEY CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTY SPLINT FINGER SPLINT FYH APOTHECARY PROCUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR