BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2820025 · Received November 5, 2012

    Report

    Report Number
    1531186-2012-01345
    Date Received
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE 6895 COMMODE SHOWER CHAIR WHEEL LOCKS WERE WRONGLY ASSEMBLED, DAMAGING THE MOUNTING HARDWARE HOLES, RESULTING IN THE WHEEL LOCKS MALFUNCTION. THERE WAS NO PATIENT INJURY REPORTED.

    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