BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4240636 · Received November 10, 2014

    Report

    Report Number
    3007231105-2014-00088
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 21, 2014
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE END USER STATES THE ARMS ON HER COMMDE ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723366 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS AQUATEC OPERATIONS GMBH 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other