BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 2971221 · Received September 6, 2007

    Report

    Report Number
    2210968-2007-00919
    Event Type
    Injury
    Date Received
    September 6, 2007
    Date of Event
    August 1, 2007
    Report Date
    September 6, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A THERMAL ENDOMETRIAL ABLATION PROCEDURE ON (B)(6) 2007. THE PT HAS EXPERIENCED A WATERY BLOODY DISCHARGE SINCE THE PROCEDURE. THE PT WAS SEEN ONE WEEK POST-OPERATIVELY WITH SOME CRAMPING AND WAS PUT ON ONE WEEK OF DOXYCYCLINE. THE PT RETURNED AT SIX WEEKS WITH A PERFUSE MALODOROUS VAGINAL DISCHARGE, NO FEVER, NO UTERINE TENDERNESS BUT SIGNS OF BACTERIAL VAGINOSIS ON WET MOUNT. HOWEVER, THE DISCHARGE OF CONCERN WAS CLEARLY COMING FROM THE CERVIX. THE PT WAS PLACED ON CLEOCIN VAGINAL CREAM.

    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 Required Intervention