BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3971379 · Received July 31, 2014

    Report

    Report Number
    1531186-2014-02913
    Date Received
    July 31, 2014
    Report Date
    June 25, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE REAR LEFT LEG IS BENT. CUSTOMER DIDN'T HAVE A LOT NUMBER BUT STATES THE UNIT WAS SOLD 3/26/2013. SHE STATES ITS A BENT ON THE FRAME PORTION NOT THE LOWER LEG. CUSTOMER HAS NO REPORTED INJURIES. CUSTOMER STATES SHE PURCHASES THROUGH (B)(6). ADVISED REPLACEMENT ITEM WILL BE ORDERED THROUGH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446777 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 96-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other