BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3970416 · Received July 31, 2014

    Report

    Report Number
    1525712-2014-04220
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER, ONE OF THE L SHAPED TUBE THAT ARE APART OF THE FRONT RIGGING HARDWARE KIT IS BROKEN. CONSUMER ADVISED THAT THE CONSUMER HIT A CURB WHEN HE WAS ACCELERATING FORWARD AND FELL OUT OF THE CHAIR. CONSUMER STATES THAT HE HURT HIS LEFT KNEE BUT NOT SURE WHAT KIND OF INJURY. CONSUMER DID SPECIFY IT WAS NO FAULT OF THE CHAIR. PROVIDER CAN SEE THAT THERE IS A BRACE ON HIS KNEE SO HE DID SEEK MEDICAL ATTENTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448018 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 2GSTMARWR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other