BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAPLE LEAF

    MDR report key: 7983914 · Received October 19, 2018

    Report

    Report Number
    7983914
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    October 3, 2018
    Report Date
    October 12, 2018
    Manufacturer
    BECKER ORTHOPEDIC APPLIANCE CO.
    Product Code
    ITS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRESSURE ULCER DEVELOPED ON THE POSTERIOR RIGHT LEG LOCATED UNDER THE BRACE. BACK OF THE BRACE WAS NOTED TO BE HARD AND APPLIED PRESSURE TO THE THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824646 MAPLE LEAF JOINT, HIP, EXTERNAL BRACE ITS BECKER ORTHOPEDIC APPLIANCE CO. 146-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other