BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3171357 · Received June 14, 2013

    Report

    Report Number
    1531186-2013-02624
    Date Received
    June 14, 2013
    Report Date
    May 20, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USER STATES THE RIGHT BRAKE CABLE IS NOT WORKING, HE SAID THE CABLE CAME OUT OF THE HANDLE. HE ALSO SAID THIS IS THE 2ND OF THESE MODELS THAT HE REC'D, HE SAID THE FIRST ONE HE GOT THE BRAKES DIDN'T WORK OUT OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271931 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other