BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXED ASSIST BAR

    MDR report key: 6124732 · Received November 21, 2016

    Report

    Report Number
    MW5066279
    Event Type
    Injury
    Date Received
    November 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    GF HEALTH PRODUCTS
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INDIVIDUAL FELL OUT OF BED. BODY WAS SEATED ON FLOOR, LEFT ARM WAS THROUGH ASSIST BAR. NO INJURY WAS SUSTAINED. ASSIST BAR REMOVED IMMEDIATELY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770339 FIXED ASSIST BAR FIXED ASSIST BAR FNL GF HEALTH PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention 7.95" TO 30". | TWO-PEDAL LOCKING SYSTEM, 500 POUND CAPACITY| ZZ78174 ZENITH 7000, 76"/80" WITH INTUITIVE