BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1141059 · Received August 29, 2008

    Report

    Report Number
    2210968-2008-00768
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 08/28/2008. ENDOMETRITIS OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES SENT AS TWO EVENTS OCCURRED. SEE ALSO MEDWATCH #2210968-2008-00746. THE SAME PT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK FOLLOWING A THERMAL ABLATION PROCEDURE, THE PT WAS READMITTED WITH FEVERS AND VAGINAL BLEEDING. A CT SCAN AND A CBC SHOWED ENDOMETRITIS. THE PT WAS TREATED WITH IV ANTIBIOTICS AND WAS DISCHARGED TWENTY FOUR HOURS LATER WITH ORAL ANTIBIOTICS.

    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 Hospitalization| R