BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3222741 · Received July 12, 2013

    Report

    Report Number
    3002416487-2013-00027
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    INVACARE CANADA KIRKLAND
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ISSUED MFR REPORT #: 300241687-2013-00027. PRODUCT REPORTED IS NOT DISTRIBUTED IN THE U.S.A. NO FDA REPORT REQUIRED.

    Description of Event or Problem · 1

    PROVIDER STATES ARM LOCK, PLASTIC BROKE OFF UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323989 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE CANADA KIRKLAND MYON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other