BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE-ANKLE-FOOT-ORTHOSIS

    MDR report key: 2392874 · Received February 22, 2007

    Report

    Report Number
    2392874
    Event Type
    Injury
    Date Received
    February 22, 2007
    Date of Event
    December 12, 2006
    Report Date
    January 12, 2007
    Manufacturer
    DESERT PROSTHETIC AND ORTHOTIC
    Product Code
    IQI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SLIDING KNEE JOINT LOCKS ON FULL THIGH TO SHOE BRACE DISENGAGED WITHOUT WARNING CAUSING PT TO FALL TO GROUND. PT WAS WEARING FULL LENGTH POLYESTER PANTS AT TIME OF INCIDENT. IT IS SUSPECTED THAT VELCRO FASTENERS ON PATELLA PORTION OF BRACE MAY HAVE ADHERED TO PANT LEG AND LIFTED JOINT LOCKS OF BRACE. PT HAS WORN SIMILAR LEG BRACES FOR MANY YEARS. PT HAD AMBULATED 25 - 30" JUST PRIOR TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNEE-ANKLE-FOOT-ORTHOSIS IQI DESERT PROSTHETIC AND ORTHOTIC

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR