BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3198137 · Received July 1, 2013

    Report

    Report Number
    1531186-2013-02866
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. REPORT # 1531186-2013-02866 INDICTING THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR AND THE COMMON DEVICE NAME AS 890.3850. THE CORRECT BRAND NAME IS MECHANICAL WALKER/ROLLATOR AND THE DEVICE NAME IS 890.3825.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    PROVIDER STATES THE BRAKE CABLE ON A 65650 ROLLATOR IS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298146 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other