BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2973275 · Received February 21, 2013

    Report

    Report Number
    1531186-2013-00717
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE 6895 COMMODE WHEEL LOCKS WERE LOOSE, ALTHOUGH IT HAVE BEEN TIGHTENED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75765 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other