BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMACHOICE

    MDR report key: 1972297 · Received January 21, 2011

    Report

    Report Number
    2210968-2011-00070
    Event Type
    Death
    Date Received
    January 21, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2010. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PT WALKED OUT OF THE OFFICE LAUGHING AND TALKING WITH HER HUSBAND. TWELVE HRS LATER, THE PT EXPIRED AT HOME. THE UNOFFICIAL CAUSE OF DEATH AS INDICATED BY THE CORONER WAS A PULMONARY EMBOLISM. AUTOPSY AND TOXOLOGY ARE BEING CONDUCTED AND REPORTS ARE EXPECTED IN SIX WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MKN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death