BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3250920 · Received July 29, 2013

    Report

    Report Number
    1531186-2013-03430
    Date Received
    July 29, 2013
    Report Date
    July 10, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE WHEELS ON THE 65960 ROLLATOR HAVE WORN PREMATURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352504 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 65960

    Patients

    Seq Age Sex Outcome Treatment
    1 Other