BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1030726 · Received April 17, 2008

    Report

    Report Number
    2210968-2008-00260
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SET TO THE FDA: 04/17/2008. CONCLUSIONS: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN ANTEVERTED UTERUS UNDERWENT A SUCCESSFUL THERMAL ENDOMETRIAL ABLATION PROCEDURE IN 2008. AFTER THE PROCEDURE, A SUPERFICIAL WHITE BURN TEN MILLIMETERS LONG AND SIMILAR IN WIDTH TO THAT OF THE CATHETER WAS SEEN ON THE POSTERIOR WALL OF THE PATIENT'S VAGINA. THE SURGEON OPINES THAT THE ANTEVERTED NATURE OF THE UTERUS WAS PROBABLY A FACTOR IN THE THERMAL INJURY. THE PATIENT WAS TREATED WITH A LOCAL ANTISEPTIC CREAM AND IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA ZEMG09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention