BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3180949 · Received June 20, 2013

    Report

    Report Number
    1525712-2013-04863
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 24, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE TDXSP-CG POWER CHAIR ALLEGEDLY TILTED ALL THE WAY BACK ON ITS OWN WHILE IN A VAN WITH THE USER SEATED IN THE CHAIR. USERS FOOT WAS SMASHED, A LITTLE BIT. NO MEDICAL INTERVENTION SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281375 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other