BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3200585 · Received July 1, 2013

    Report

    Report Number
    3007231105-2013-00040
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 6, 2013
    Manufacturer
    AQUATEC OPERATIONS GMBH
    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

    DEALER STATED THAT ONE OF THE FOOT PEGS ON A H112-5 BATH BOARD BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298062 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX AQUATEC OPERATIONS GMBH H112-5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other