BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3576838 · Received January 15, 2014

    Report

    Report Number
    1525712-2014-00295
    Date Received
    January 15, 2014
    Date of Event
    November 27, 2013
    Report Date
    January 8, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Removal / Correction Number
    Z-2270-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE OWNERS MANUAL FOR THE TDXSP POWER WHEELCHAIR (PART NO 1143190 / REV K - 03/11) PAGE 23: "DO NOT USE THE FOOTPLATES AS A PLATFORM. WHEN GETTING IN OR OUT OF THE WHEELCHAIR, MAKE SURE THAT THE FOOTPLATES ARE IN THE UPWARD POSITION OR SWING FOOTRESTS TOWARDS THE OUTSIDE OF THE WHEELCHAIR".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER STOOD UP ON THE FOOT BOARD OF THE POWER WHEELCHAIR WHILE THE CHAIR WAS STOPPED. WHILE STANDING, THE CHAIR UNEXPECTEDLY MOVED FORWARD CAUSING THE END USER TO FALL FORWARD. END USER SUSTAINED BRUISING ON THE ARMS AND WRIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40257 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 Other