BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1012571 · Received March 12, 2008

    Report

    Report Number
    2210968-2008-00156
    Event Type
    Injury
    Date Received
    March 12, 2008
    Report Date
    February 11, 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 SENT TO THE FDA: 03/12/2008. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. 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 PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON AN UNK DATE. DURING THE PROCEDURE, PRESSURE COULD NOT BE OBTAINED. THE SURGEON TRIED SEVERAL TIMES WITH THE SAME CATHETER AND THEN ABANDONED THE PROCEDURE. A HYSTEROSCOPY WAS PERFORMED AND THE UTERUS APPEARED TO BE RUPTURED. A LAPAROSCOPY WAS PERFORMED AND THE UTERUS WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA ZHMG01

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention