BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3895187 · Received June 25, 2014

    Report

    Report Number
    1525712-2014-03187
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE SCREW IS THREADED THAT HOLDS THE BOLT TO THE BACK RECLINE IN PLACE IS FALLING OUT CAUSING THE BACK TO COLLAPSE ON A SOLARA3G WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371888 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other