BEUDAMED
    FDA Adverse Event Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4131162 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06517
    Date Received
    October 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT HE WAS DRIVING HIS M51P POWER CHAIR OUTSIDE OF THE LIBRARY AND HIT A CURB CAUSING THE CHAIR TO TIP OVER. USER WAS STILL PARTIALLY IN THE CHAIR WHEN IT TIPPED, CHAIR WENT ON HIS LEFT ELBOW. USER STATES THERE WAS A SCRAPE AND IT WAS BLEEDING, A LIBRARY WORKER BANDAGED HIM UP. NO ALLEGED MALFUNCTION OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612929 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other