BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2942770 · Received February 4, 2013

    Report

    Report Number
    1531186-2013-00402
    Date Received
    February 4, 2013
    Report Date
    January 16, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1531186-2013-00402 INDICTING THE MANUFACTURER AS INVACARE. THE ACTUAL MANUFACTURER IS UNKNOWN, 2 POSSIBLE SUPPLIERS.

    Description of Event or Problem · 1

    PER DEALER WELD IS BROKEN ON BACK AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46293 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 65851B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other