BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3962455 · Received July 29, 2014

    Report

    Report Number
    1531186-2014-02786
    Date Received
    July 29, 2014
    Report Date
    June 20, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, CHAIR HAS COLLAPSED CAUSING USER TO FALL IN THE TUB AND HURT HIS TAILBONE. THE PLASTIC CLIPS HOLDING THE LEGS TO THE CHAIR BOTTOM ARE TOO SHORT AND POP OUT WHEN THE BATHER MOVES AROUND ON THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442113 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other