BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3895103 · Received June 25, 2014

    Report

    Report Number
    1525712-2014-03181
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE 6291-3F WALKER IS WOBBLY DUE TO LEFT SIDE FOLDS IN SOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372101 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 6291-3F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other