BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4121019 · Received September 26, 2014

    Report

    Report Number
    1531186-2014-04442
    Date Received
    September 26, 2014
    Report Date
    June 25, 2014
    Manufacturer
    AQUATEC OPERATIONS GMBH
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER STATES THE LEG OF THE COMMODE CAVED IN AND THE USER FELL TO THE FLOOR. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601615 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS AQUATEC OPERATIONS GMBH 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other