BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2940257 · Received February 2, 2013

    Report

    Report Number
    3002416487-2013-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    January 31, 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

    MDR DECISION DATE: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PROVIDER STATES THERE IS A CRACK ON THE PLASTIC PART NEAR THE LEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45566 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE CANADA KIRKLAND 1492315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other