BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4180378 · Received October 17, 2014

    Report

    Report Number
    1525712-2014-07038
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 29, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER THE END-USER, THE UNIT'S SEAT IS CRACKED ON THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662794 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other