BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1222125 · Received November 5, 2008

    Report

    Report Number
    2210968-2008-01070
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 31, 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: 11/05/2008. INFECTION OCCURRED - CONCLUSION CODE: 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 PATIENT UNDERWENT A HYSTEROSCOPY WITH A FLEXIBLE HYSTEROSCOPE, AN ENDOMETRIAL BIOPSY, AND AN ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008, THIRTEEN DAYS LATER, THE PATIENT COMPLAINED OF PERFUSE WATERY DISCHARGE CAUSING IRRITATION OF THE VULVA. THE PATIENT WAS TREATED WITH DIFLUCAN AND TERAZOL ON AN UNKNOWN DATE.

    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