BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3180995 · Received June 20, 2013

    Report

    Report Number
    1531186-2013-02714
    Date Received
    June 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    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

    (B)(6) STATES THERE ARE MULTIPLE ISSUES WITH THIS CHAIR THE BOTTOM OF THE SEAT IS COMING APART ((B)(4)), THE LEFT WHEEL IS WOBBLY ((B)(4)) AND THE LEFT ARM IS NOT LOCKING IN ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280513 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other