BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3910785 · Received July 2, 2014

    Report

    Report Number
    1525712-2014-03361
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    May 30, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PER END USER'S FAMILY MEMBER, THE ADJUSTMENT KNOB WILL NOT HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387178 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS UNKNOWN 1302RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other