BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3954468 · Received July 24, 2014

    Report

    Report Number
    1531186-2014-02766
    Date Received
    July 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ARM IS BROKEN ON LEFT SIDE CAUSING SCRATCH TO END USERS ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434224 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 1302RTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other