BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2771350 · Received October 4, 2012

    Report

    Report Number
    1531186-2012-01094
    Date Received
    October 4, 2012
    Report Date
    October 2, 2012
    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

    DEALER CALLED STATING THAT THE WHEEL LOCKS ON THE 6895 SHOWER COMMODE CHAIR ALLEGEDLY ARE COMING APART. REPLACEMENT PARTS ON WARRANTY ORDER (B)(4). NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other