BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1002550 · Received February 26, 2008

    Report

    Report Number
    2210968-2008-00112
    Event Type
    Injury
    Date Received
    February 26, 2008
    Report Date
    January 28, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 IN 2008 WITHOUT INCIDENT. SEVERAL WEEKS AFTER THE PROCEDURE, A TUBAL OVARIAN ABCESS WAS DISCOVERED AND THE PT'S OVARY WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention