BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3227888 · Received July 15, 2013

    Report

    Report Number
    1531186-2013-03177
    Date Received
    July 15, 2013
    Report Date
    June 24, 2013
    Manufacturer
    KENSTONE METAL
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1531186-2013-03177 INDICTING THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR WITH COMMON DEVICE NAME AS 890.3850. THE CORRECT BRAND NAME IS MECHANICAL WALKER, ROLLATOR, CORRECT COMMON DEVICE NAME IS 890.3825.

    Description of Event or Problem · 1

    DEALER STATES RIGHT BRAKE NO LONGER FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326486 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ KENSTONE METAL 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other