BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 3122684 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05744
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, 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 UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THE CATHETER WAS PRIMED AT 198 MMHG. THE CYCLE STARTED AT A PRESSURE OF 195 MMHG. NO FLUID WAS ADDED. THE UTERUS CONTRACTED ONCE, CAUSING THE GENERATOR TO CUT OUT DURING HEATING CYCLE. A STABLE PRESSURE AND TEMPERATURE WERE NOTED AT RESTART AND THROUGHOUT PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 WITH ACUTE ABDOMINAL PAIN. A CT OF THE ABDOMEN CONFIRMED A LITTLE BIT OF PUS IN THE ABDOMEN. THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC, TACOZIN IV. THE PATIENT¿S C-REACTIVE PROTEIN WAS 139. ON (B)(6), THE PATIENT HAD LESS PAIN. ON (B)(6), THE C-REACTIVE PROTEIN WAS 136 AND THE PATIENT UNDERWENT A LAPAROSCOPY. SHE WAS DIAGNOSED WITH ACUTE SALPINGITIS WITH PUS IN THE POUCH OF DOUGLAS AND INSIDE THE LEFT TUBE. THE PHYSICIAN DID A RESECTION OF THE LEFT TUBE AND CLEANED OUT THE POUCH OF DOUGLAS. ON THE (B)(6) 2013, THE C-REACTIVE PROTEIN CAME DOWN, THE PATIENT CLINICALLY IMPROVED, AND WAS DISCHARGED. THE PATIENT RETURNED (B)(6) 2013 FOR A FOLLOW UP COMPLAINING OF PAIN WHILE PASSING STOOL AND A VERY TENDER UTERUS WITH NO PERITONITIS. THE PATIENT WAS ADMITTED AND IS CURRENTLY HAVING AN ABDOMINAL X-RAY AND BLOOD HAS BEEN ORDERED FOR A C-REACTIVE PROTEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224572 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON, INC. NA EGMG13

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R