BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4150816 · Received October 8, 2014

    Report

    Report Number
    1525712-2014-06799
    Date Received
    October 8, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 6, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT DURING A GENERAL CONVERSATION WITH THEIR CONSUMER IT WAS MENTIONED THAT WHEN THE END USER WAS GETTING OUT OF THE VAN THE ATTENDANT DID NOT SET THE BRAKES CORRECTLY CAUSING THE END USER TO FALL OFF THE RAMP, SUSTAINED UNDETERMINED INJURY. DEALER STATES THAT SHE MADE IT CLEAR THAT THE END USER'S INJURY WAS NO WAY RELATED TO THE DEVICE. THE CHAIR WORKS FINE. THIS WAS MENTIONED IN A GENERAL CONVERSATION WITH THE DEALER, BECAUSE OF END USER'S NOT PROPERLY USING THE EQUIPMENT. NO MALFUNCTION OF THE PRODUCT. FILING WITH THE FDA BASED ON UNKNOWN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632956 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SPRXT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other