BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3071905 · Received April 22, 2013

    Report

    Report Number
    1525712-2013-03140
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    November 26, 2012
    Report Date
    March 27, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    POTENTIAL FOR INJURY ASSOCIATED WITH AN M91 POWER CHAIR BACK WHEEL FALLING OFF. THIS CAN CAUSE THE DEVICE TO BE UNSTABLE AND MAY CAUSE INJURY TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172837 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91

    Patients

    Seq Age Sex Outcome Treatment
    1 68 Other