BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3800586 · Received May 8, 2014

    Report

    Report Number
    1525712-2014-02339
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 2, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    M61 POWER WHEEL CHAIR RANDOMLY PICKS UP AND RUNS END USER INTO DOORS AND CLOSETS RESULTING IN HOLES IN THE DOORS. END USER HAS ALSO HIT HER RIGHT ELBOW ON THE WALL AND SCRAPED HER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279380 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M61

    Patients

    Seq Age Sex Outcome Treatment
    1 69 Other