BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3103458 · Received May 9, 2013

    Report

    Report Number
    1525712-2013-03659
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR. REPORT # 1525712-2013-03659 INDICATING THE MANUFACTURER AS UNKNOWN. THE ACTUAL MANUFACTRER IS KENSTONE METAL.

    Description of Event or Problem · 1

    PER END USER THE PIECE IS BROKEN OFF THAT HOLDS THE WHEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203517 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other