BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3000643 · Received March 12, 2013

    Report

    Report Number
    1525712-2013-01907
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 15, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    REF (B)(4), DEALER STATES THAT THE HINGE IS BENT. EXPLAINED THAT IT MAY NOT BE COVERED UNDER WARRANTY FOR BEING BENT. DEALER WILL JUST TAKE OUT THE BAD HINGE AND RETURN THE NEW HARDWARE ALONG WITH HIS BAD PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104199 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other