BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3227619 · Received July 15, 2013

    Report

    Report Number
    1531186-2013-03150
    Date Received
    July 15, 2013
    Report Date
    June 21, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR. REPORT # 1531186-2013-03150 INDICTING THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR WITH COMMON DEVICE NAME AS 890.3850, PRODUCT CODE AS IOR AND MANUFACTURER AS UNKNOWN. THE CORRECT BRAND NAME IS MECHANICAL WALKER, ROLLATOR, CORRECT COMMON DEVICE NAME IS 890.3825, CORRECT PRODUCT CODE IS ITJ AND CORRECT MANUFACTURER IS KENSTONE.

    Description of Event or Problem · 1

    PROVIDER STATES BRAKE CABLE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326441 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other