BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3821709 · Received May 20, 2014

    Report

    Report Number
    1525712-2014-02538
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 8, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    R51 POWER WHEEL CHAIR VEERED WHILE END USER WAS GOING THROUGH A DOORWAY. PANELING AROUND DOORWAY IS COMING LOOSE AND INJURED HER LEFT FOOT. END USER SUSTAINED BRUISING, SWELLING AND BLOOD ON HER FOOT. END USER DID NOT SEEK OUTSIDE MEDICAL ATTENTION, HER HUSBAND BANDAGED HER WOUND. PER END USER TWO WEEKS LATER THE INJURY BECAME A BLOOD BLISTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298460 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET R51

    Patients

    Seq Age Sex Outcome Treatment
    1 43 Other