BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3840449 · Received May 30, 2014

    Report

    Report Number
    1525712-2014-02761
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2013
    Report Date
    April 16, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE END USER EXPERIENCED A DECREASE IN SPEED AND THEN UNINTENDED ACCELERATION IN A TDXSP-MCG POWER CHAIR. IT IS ALLEGED THAT THE END USER WAS THROWN FROM THE CHAIR, AND WAS TREATED AT THE HOSPITAL FOR A HEAD LACERATION AND VERTIGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318204 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other