BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3766272 · Received April 23, 2014

    Report

    Report Number
    1525712-2014-02055
    Event Type
    Death
    Date Received
    April 23, 2014
    Report Date
    April 18, 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 FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE END USERS WIFE THAT HER HUSBAND ALLEGEDLY HAD AN (UNKNOWN) ACCIDENT WITH HIS (B)(4) POWER CHAIR, SHE FOUND HIM IN THE LIVING ROOM WITH A CUT ON HIS LEG, USER ALLEGEDLY BLED TO DEATH. UNKNOWN MALFUNCTION. FILE WILL BE UPDATED AS ADDITIONAL INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247745 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death