BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNEE IMMOBILIZER, 20IN, SUPERLITE, STAIGHT, L

    MDR report key: 3966725 · Received June 3, 2014

    Report

    Report Number
    3005225477-2014-00014
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 15, 2014
    Report Date
    June 2, 2014
    Manufacturer
    DEROYAL GUATEMALA
    Product Code
    ITQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HOOK AND LOOP WHICH HOLDS THE TOP OF THE BRACE IS PROBLEMATIC. THE TOP HOOKS WERE AGAINST THE SKIN ON HER LEFT LEG WHICH CAUSED AN IRRITATION/REACTION/RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323373 KNEE IMMOBILIZER, 20IN, SUPERLITE, STAIGHT, L JOINT, KNEE, EXTERNAL BRACE ITQ DEROYAL GUATEMALA

    Patients

    Seq Age Sex Outcome Treatment
    1