BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3044379 · Received April 9, 2013

    Report

    Report Number
    1525712-2013-02659
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 12, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2013 - RBS - THE DEALER REPORTED THAT THE PATIENT WAS DRIVING THE TDXSIV CUSTOM POWER WHEELCHAIR WHEN THE UNIT WAS HIT BY A CAR. NO PRODUCT MALFUNCTION WAS ALLEGED. HOWEVER, THE PATIENT SUSTAINED UNSPECIFIED INJURIES, AND MEDICAL ATTENTION WAS SOUGHT. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVISED, AND A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146499 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSIV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other