BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1883819 · Received October 22, 2010

    Report

    Report Number
    2210968-2010-01366
    Event Type
    Injury
    Date Received
    October 22, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - HEMATOMETRA OCCURRED - (B)(4): 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)2010. THE PROCEDURE WENT WELL AND THERE WERE NO COMPLICATIONS. ON (B)(6)2010, THE PT CAME IN WITH SYMPTOMS OF PAIN, BLOATING, MILD CRAMPING, AND AN INCREASE IN PELVIC PRESSURE. UPON EXAM, THE CERVIX WAS STENOTIC AND NONE OF THE USUAL DISCHARGE WAS SEEN FOR THE FIRST WEEK POST-OPERATIVELY. ENDOMETRIAL ASPIRATION REVEALED 12CC OF SEROSANGUINOUS FLUID. THE SYMPTOMS INITIALLY RESOLVED, THEN RETURNED. THEN THE CERVIX WAS DILATED TO 5MM WITH A RETURN OF A LARGE AMOUNT OF SEROSANGUINOUS FLUID. THE SURGEON IS GOING TO HAVE TO USE CYTOTEC TO KEEP THE CERVIX OPEN AND WILL CONSIDER ANTIBIOTIC COVERAGE.

    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 Required Intervention