BEUDAMED
    FDA Adverse Event Death Summary report: N

    TDX SP2 BASE FOR REHAB SEATING

    MDR report key: 11843321 · Received May 18, 2021

    Report

    Report Number
    1525712-2021-00004
    Event Type
    Death
    Date Received
    May 18, 2021
    Report Date
    April 20, 2021
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS FILING, IT IS NOT KNOWN IF THE WHEELCHAIR MALFUNCTIONED OR IF THE PATIENT WAS SMOKING. INVACARE WAS MADE AWARE OF THIS EVENT THAT OCCURRED IN (B)(6) WITH A TDX-SP2-NB WHEELCHAIR. THIS RECORD WAS CREATED DUE TO THE U S. MANUFACTURED TDXSP2 BEING SIMILAR IN DESIGN AND WOULD LIKELY TO HAVE THE SAME ADVERSE OUTCOME AS THIS EVENT. THE TDX-SP2-NB WHEELCHAIR HAS NOT BEEN RETURNED TO INVACARE FRANCE FOR AN EVALUATION.

    Description of Event or Problem · 1

    THE NEIGHBORS OF A (B)(6)-YEAR-OLD WOMAN, SAW SMOKE COMING OUT FROM HER APARTMENT. THEY CALLED THE FIRE DEPARTMENT, AND WHEN THEY ARRIVED, THEY FOUND THAT THE WHEELCHAIR HAD CAUGHT FIRE, AND THE END-USER THAT WAS SITTING IN IT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738689 TDX SP2 BASE FOR REHAB SEATING WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET NA:TDXSP2

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death