BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHUREMED

    MDR report key: 6137880 · Received November 29, 2016

    Report

    Report Number
    MW5066434
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 29, 2016
    Manufacturer
    SCHUERCH CORPORATION
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PLASTIC STRAP ADJUSTER LOOSENED WHEN PT'S LEG WAS ELEVATED IN THE STIRRUP. PT'S LEG FELL FROM STIRRUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784490 SCHUREMED ANKLE STRAP STIRRUP FWZ SCHUERCH CORPORATION 508-0506

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR