BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3807005 · Received May 13, 2014

    Report

    Report Number
    1531186-2014-01607
    Date Received
    May 13, 2014
    Report Date
    March 27, 2014
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    LEFT WHEEL BEARING WORE OUT AND FELL OUT OF WHEEL ON A 6895 SHOWER CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286333 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other