BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3100744 · Received May 8, 2013

    Report

    Report Number
    1531186-2013-01963
    Date Received
    May 8, 2013
    Report Date
    April 12, 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

    DEALER STATED THE RIGHT BACK CASTER RIM CRACKED IN SEVERAL PIECES AROUND THE AXLE AND WHEEL. END USER MEETS WEIGHT SPECS AND CLAIMED IT HAPPENED DURING NORMAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200504 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other