BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3005524 · Received March 14, 2013

    Report

    Report Number
    1525712-2013-01994
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 18, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) 2013 - RBS -THE DEALER REPORTED THAT THE CXE CUSTOM MECHANICAL WHEELCHAIR HAD TWO STRIPPED SCREWS HOLDING THE ARMS ASSEMBLY TO THE FRAME. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107425 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CXE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other