BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1315699 · Received February 17, 2009

    Report

    Report Number
    2210968-2009-00123
    Event Type
    Injury
    Date Received
    February 17, 2009
    Date of Event
    December 12, 2008
    Report Date
    January 21, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BRUISING OCCURRED - BLEEDING OCCURRED - CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION 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 IN LATE 2008. POST-OPERATIVELY IN THE EVENING, THE PT EXPERIENCED SEVERE ABDOMINAL PAIN, HARDNESS IN THE ABDOMEN, AND HEAVY BLEEDING. FIVE DAYS LATER, THE PT INFORMED THE SURGEON OF HEAVY BLEEDING AND SEVERE CRAMPING AND TWO LARGE BRUISED AREAS ON EACH FLANK THE SIZE OF A FIST. THE PT UNDERWENT TWO COMPLETE BLOOD COUNTS AT THE LABORATORY AND HAS A HEMOGLOBIN OF 9.9. IN EARLY 2009, THE PT WAS SEEN BY THE SURGEON WHO STATED THAT "THIS WAS NORMAL" AND THE PT WAS SCHEDULED FOR RE-VISIT IN APPROX TWO MONTHS LATER. THREE DAYS LATER, THE PT HAD ANOTHER HEAVY PERIOD WITH SEVERE CRAMPING WITH FLOW THAT WAS BROWNISH IN COLOR WITH STRONG ODOR. TWELVE DAYS LATER THE PATIENT STOPPED TAKING HER DIABETIC MEDICATION AND PLANS TO SEE HER FAMILY PHYSICIAN THE FOLLOWING MONTH. THE PT HAS ALSO EXPERIENCED LOWER BACK PAIN WHILE LYING SINCE THE PROCEDURE.

    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 42 YR