BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3073632 · Received April 23, 2013

    Report

    Report Number
    1525712-2013-03204
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH A TDXSP-MCG POWER CHAIR WITH THE RIGHT DRIVE TIRE OFF THE GROUND. THIS COULD CAUSE THE DEVICE TO BECOME UNSTABLE AND MAY CAUSE INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174336 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other