BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4234131 · Received November 7, 2014

    Report

    Report Number
    1531186-2014-05427
    Date Received
    November 7, 2014
    Report Date
    October 20, 2014
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER STATED, THE WHEELS ON THE ROLLATOR HAVE DRY ROTTED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716930 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other