BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4052044 · Received September 2, 2014

    Report

    Report Number
    3007231105-2014-00049
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Report Date
    August 7, 2014
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER ALLEGED CROSSBAR PLASTIC SNAPPED OFF UNIT DUE TO WEAK PLASTIC. CUSTOMER UNDER WEIGHT CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533951 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS AQUATEC OPERATIONS GMBH 1535003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other