BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3252886 · Received July 29, 2013

    Report

    Report Number
    1531186-2013-03453
    Date Received
    July 29, 2013
    Report Date
    July 11, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED THAT THE LEFT SIDE LEGS ON A 96-2 SHOWER CHAIR ARE WOBBLY. USER HAS FALLEN, SUSTAINING BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351949 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 96-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other