BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3163547 · Received June 11, 2013

    Report

    Report Number
    1525712-2013-04566
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A BENT CASTER FORK ON A SOLARA3G MANUAL WHEELCHAIR. THIS EVENT COULD CAUSE PRODUCT INSTABILITY AND THE POTENTIAL FOR THE CHAIR TO TIP OVER OR THE USER TO BECOME STRANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264476 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other