BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2944785 · Received February 5, 2013

    Report

    Report Number
    1531186-2013-00423
    Date Received
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, THE LEFT WHEEL IS LOOSE AND LOSING PIECES OF BEARINGS. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48477 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly