BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3910917 · Received July 2, 2014

    Report

    Report Number
    1531186-2014-02334
    Date Received
    July 2, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 30, 2014
    Manufacturer
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATES THE FOOTPLATE IS BROKEN AT THE WELD DUE TO THE REPOSITIONING OF THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386533 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD 6795

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other