BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4077606 · Received September 10, 2014

    Report

    Report Number
    1531186-2014-04012
    Date Received
    September 10, 2014
    Report Date
    August 18, 2014
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE LEFT SIDE CABLE HAS BROKEN LOOSE FROM THE BRAKE HANDLE. AND THE RIGHT SIDE THE CABLE IS BENT DOWN AND REALLY LOOSE LOT # KS110508. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557093 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other