BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3776301 · Received April 28, 2014

    Report

    Report Number
    1531186-2014-01557
    Date Received
    April 28, 2014
    Report Date
    March 25, 2014
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER ADVISED BRAKES WILL NOT HOLD BECAUSE BOLTS AND NUTS ARE COMING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255244 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 66 MO Other