BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3501025 · Received December 5, 2013

    Report

    Report Number
    1531186-2013-05742
    Event Type
    Malfunction
    Date Received
    December 5, 2013
    Date of Event
    December 2, 2013
    Report Date
    December 2, 2013
    Manufacturer
    INVACARE CANADA KIRKLAND
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED WAS INADVERTENTLY FILED UNDER MFR REG # (B)(4). THE CORRECT MFR REG # IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BEARINGS ON A MANUAL WHEELCHAIR WERE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630246 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE CANADA KIRKLAND MYONADLT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other