BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4201872 · Received October 27, 2014

    Report

    Report Number
    1525712-2014-07273
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Report Date
    October 3, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THE BACK FRAME DOES NOT HAVE THE HOLES DRILLED CORRECTLY TO FASTEN THE BACK TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681999 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN SELFCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other