BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1611364 · Received February 18, 2010

    Report

    Report Number
    2210968-2010-00122
    Event Type
    Injury
    Date Received
    February 18, 2010
    Report Date
    January 18, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4) BLEEDING. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL 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) 2009. THE PT NOTED SOME CRAMPING DURING PROCEDURE. THE PT HAD WATERY VAGINAL DISCHARGE UNTIL (B) (6) 2009 WHEN IT TURNED INTO VAGINAL BLEEDING LIKE A MENSTRUAL PERIOD. IT THEN WENT BACK TO WATERY RED DISCHARGE. ON (B) (6) 2010, THE SURGEON EXAMINED THE PT AND FOUND THAT THE PT'S CERVIX WAS BLEEDING "MAYBE FROM AN ABRASION". THE PT WAS PRESCRIBED CLINDAMYCIN 300MG TWICE DAILY FOR SEVEN DAYS.

    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 50 YR Required Intervention