BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1315700 · Received February 17, 2009

    Report

    Report Number
    2210968-2009-00122
    Event Type
    Injury
    Date Received
    February 17, 2009
    Report Date
    January 16, 2009
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BLEEDING OCCURRED - CONCLUSION: 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 PT HAD AN UNEVENTFUL VAGINAL DELIVERY IN 2008. THE PT THEN UNDERWENT A LAPAROSCOPIC TUBAL STERILIZATION, DILATATION AND CURETTAGE, AND AN ENDOMETRIAL THERMAL ABLATION TWO MONTHS LATER, POSTPARTUM DAY TWENTY ONE. THE PT THEN DEVELOPED PELVIC PAIN AND BLEEDING AND UNDERWENT SUCTION DILATATION AND CURETTAGE AND WAS TREATED WITH BACTRIM. THESE WERE UNDER THE CARE OF ANOTHER SURGEON. THE PT CONTINUED TO HAVE PELVIC PAIN AND BLEEDING AND WAS REFERRED TO ANOTHER SURGEON. THE PT WAS THEN TREATED WITH ROCEPHIN. SONOGRAPHY REVEALED AN ABUNDANCE OF TISSUE IN THE UTERINE CAVITY. SHE UNDERWENT HYSTEROSCOPY AND REPEAT DILATATION AND CURETTAGE THE FOLLOWING MONTH. PATHOLOGY REVEALED ACUTE INFLAMMATION AND NECROTIC TISSUE AS WELL AS SMOOTH MUSCLE. THE PT CONTINUES WITH BLEEDING, PELVIC PAIN, AND NOW SOME RIGHT UPPER QUADRANT PAIN. THE SURGEON OPINES THAT THE THERMAL ABLATION WAS PERFORMED SO SOON POSTPARTUM THAT THE UTERUS MAY HAVE PRODUCED INADEQUATE TREATMENT WHICH NOW IS CONTINUING TO SLOUGH. THE SURGEON INTENDS TO PERFORM A LAPAROSCOPY AND POSSIBLY A HYSTERECTOMY.

    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 34 YR Required Intervention