BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1063122 · Received June 20, 2008

    Report

    Report Number
    2210968-2008-00430
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT UNDERWENT A THERMAL ENDOMETRIAL ABLATION IN 2008. DURING THE PROCEDURE, WHEN THE DEVICE WAS PUT INTO THE UTERUS AND THE MACHINE TURNED ON, THE PATIENT EXPERIENCED SEVERE PAIN. THE PROCEDURE CONTINUED FOR EIGHT MINUTES AND THE PATIENT WAS IN EXTREME PAIN. THE CASE WAS NOT ABORTED AND THE PAIN CONTINUED AFTER THE DEVICE WAS REMOVED. THE PATIENT REMAINED IN THE OFFICE FOR THREE HOURS WITH PAIN DESCRIBED AS LEVEL "7" AFTER THE PROCEDURE. THE PATIENT COULD NOT WALK ON HER OWN AND WAS ADMITTED TO THE HOSPITAL FOR HYDRATION AND PAIN MANAGEMENT. THE PATIENT STAYED IN THE HOSPITAL OVERNIGHT AND WAS DISCHARGED THE NEXT DAY.

    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 UNK Hospitalization| R