BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3175879 · Received June 18, 2013

    Report

    Report Number
    1525712-2013-04777
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Report Date
    May 22, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BROKEN SEAT FOLD BACK PIN ON THE CRF MANUAL WHEELCHAIR. THIS EVENT COULD PREVENT USER FROM HAVING ADEQUATE UPPER BODY SUPPORT AND POSSIBLY CAUSE USER TO UNEXPECTEDLY FALL BACK INTO A RECLINED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274829 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CRF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other