BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3120566 · Received May 20, 2013

    Report

    Report Number
    1531186-2013-02134
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR REPORT # 1531186-2013-02134 INDICTING THE MANUFACTURER AS UNKNOWN. THE CORRECT MANUFACTURER IS KENSTONE METAL.

    Description of Event or Problem · 1

    PROVIDER STATES WHEELS WEARING STRANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221359 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other