BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3062098 · Received April 16, 2013

    Report

    Report Number
    1525712-2013-02907
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 20, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH SOLARA3G MANUAL WHEELCHAIR TILTING ON ITS OWN DUE TO THE TEETH JUMPING ON THE RACK. THIS EVENT COULD EVENTUALLY LEAD TO USER BECOMING STRANDED IN A TILT POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162786 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET 3G SOLARA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other