BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3971614 · Received July 31, 2014

    Report

    Report Number
    1531186-2014-02926
    Date Received
    July 31, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, UNIT IS OFF KILTER AND WOBBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448309 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX AQUATEC OPERATIONS GMBH 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other