BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1600474 · Received February 4, 2010

    Report

    Report Number
    2210968-2010-00102
    Event Type
    Injury
    Date Received
    February 4, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 7, 2010
    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

    (B) (4). (B) (4) - PAIN OCCURRED. 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 AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B) (6) 2009. PRIOR TO THE PROCEDURE THE DOCTOR PERFORMED A HYSTEROSCOPY. THE RESULTS WERE UNREMARKABLE AND HE DID NOT NOTE A PREVIOUS ESSURE IMPLANTATION. TEN DAYS POST-OPERATIVELY, THE PT WENT TO THE EMERGENCY ROOM DUE TO PELVIC PAIN. A SONOGRAM WAS DONE. THE PT WAS AFEBRILE. THE PT WAS GIVEN VICODIN AND SENT HOME. THE SURGEON SAW THE PT FOR A FOLLOW UP VISIT WITH INCREASING PELVIC PAIN. AN EXAM FOUND THE ADNEXA UNREMARKABLE BUT THE UTERUS WAS MARKEDLY TENDER. THE PT WAS EXPERIENCING LIGHT BLEEDING/DISCHARGE, BUT WAS STILL AFEBRILE AND HAD NO BOWEL SYMPTOMS. AS OF (B) (6) 2010, THE PT WAS GIVEN NSAIDS, HAD COMPLETED A COURSE OF CIPRO, STARTED A COURSE OF DOXYCYCLINE, AND PLANNED TO HAVE A FOLLOW-UP APPOINTMENT.

    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 Required Intervention