BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3103560 · Received May 9, 2013

    Report

    Report Number
    1531186-2013-01990
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE TRANSFER BENCH SEAT WAS CRUSHED. THIS ISSUE COULD CAUSE PRODUCT INSTABILITY AND THE SEAT COULD CRACK IN HALF AND THE USER COULD FALL OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204329 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 98071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other