BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3973297 · Received August 1, 2014

    Report

    Report Number
    1525712-2014-04225
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    January 24, 2014
    Report Date
    June 27, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    TBM ADVISED ENDUSER GOING DOWN CURB AND CHAIR TILTED TO THE RIGHT AND HIS BODY SHIFTED AND FELL FACE FIRST ONTO THE CONCRETE, ENDUSER DOES NOT HAVE A RIGHT ARM TO STABILIZE HIMSELF, TBM ADVISED ENDUSER HAS SCRAPES ON HIS FACE WITH BLOOD, TBM ADVISED ENDUSER DID NOT ADVISE IF HE SEEKED MEDICAL ATTENTION BUT NEIGHBOR CAME OVER TO HELP HIM, TBM COULD NOT PROVIDE ANY FURTHER INFORMATION. MADE AWARE OF THIS SITUATION OF INJURY 8AM (B)(6) 2014 ACCIDENT OCCURED BACK IN (B)(6) 2014 BUT DIDN'T NOTIFY INVACARE OF VA OF ACCIDENT NEED RIGHT DESK LENGTH ADJUSTABLE ARM REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450993 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 3GAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other