BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1130476 · Received August 20, 2008

    Report

    Report Number
    2210968-2008-00714
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 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
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A ENDOMETRIAL THERMAL ABLATION PROCEDURE IN 2008. THIRTY MINUTES AFTER THE PROCEDURE, AFTER THE PT ARRIVED HOME, THE PT EXPERIENCED INTENSE PAIN AND WAS TREATED WITH VICODIN AND MOTRIN 800MG, THEN VOMITED. THE PT TOOK ONE PILL FOR NAUSEA WHICH HAD BEEN PRESCRIBED AS NEEDED AS PER THE SURGEON'S POST-OPERATIVE ROUTINE. INITIALLY, THE PAIN WAS NOT RELIEVED BY THE FIRST DOSE OF VICODIN BUT WAS RELIEVED AFTER THE SECOND DOSE. IN "THE NEXT DAY" THE PT WAS FEELING BETTER. AT ABOUT 2 DAYS LATER, THE PT VOMITED ONCE AND EXPERIENCED DIARRHEA ONCE, THEN FELT BETTER. CURRENTLY, THE PT EXPERIENCES A PERSISTENT SENSATION OF BLOATING.

    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 47 YR Required Intervention