BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3955197 · Received July 24, 2014

    Report

    Report Number
    3007231105-2014-00035
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THAT THE COMMODE IS WOBBLY AND THE CONSUMER DOES NOT FEEL COMFORTABLE USING IT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434237 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS AQUATEC OPERATIONS GMBH 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other