BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 726597 · Received June 16, 2006

    Report

    Report Number
    2210968-2006-00433
    Event Type
    Injury
    Date Received
    June 16, 2006
    Date of Event
    December 29, 2005
    Report Date
    May 18, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    p970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASHERMAN'S SYNDROME IS A SCARRING WITHIN THE ENDOMETRIAL CAVITY THAT CAN OCCUR WITH A VERY VIGOROUS D&C, ACUTE ENDOMETRITIS, OR PROCEDURES DESIGNED TO ABLATE ENDOMETRIUM, REGARDLESS OF THE ENERGY USED TO DO SO. HOWEVER, IT GENERALLY WOULD NO CREATE PAIN. WHAT MIGHT CREATE PAIN IS A SIGNFICANT DEGREE OF CERVICAL STENOSIS CAUSING MARKED CRAMPING IN AN ATTEMPT TO EXPEL THE COLLECTED BLOOD. THIS, AGAIN, CAN OCCUR WITH ANY ABLATION PROCEDURE BUT ACTUALLY IS UNCOMMON. IT IS LIKELY THAT IF THE POSTOPERATIVE INFECTION WAS ENDOMETRISTIS, IT WOULD CAUSE INCREASED SCARRING IN THE UTERINE CAVITY AND INCREASE THE RISK OF PAIN OCCURING WITH CONTINUED BLEEDING. THE PROBLEM IS GENERALLY RESOLVED BY DILATING THE CERVIX, THOUGH RARELY IT CAN RECUR IF THE CERVIX SHOULD STENOSE AGAIN. CLEARLY, THIS IS NOT COMPLETE CERVICAL STENOSIS AS THE PATIENT IS HAVING SPOTTING. THIS WOULD BE RELATED TO THE PROCEDURE BUT NOT THE DEVICE. PMA # IS P970021

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A BALLOON ABLATION PROCEDURE IN 2005. POSTOPERATIVELY, THE PATIENT REPORTED SPOTTING ACCOMPANIED BY PAIN WHICH WAS TREATED WITH MEDICATION AND A POSTOPERATIVE INFECTION WAS TREATED WITH ANTIBIOTICS. A NURSE AS SUGGESTED THAT THE PAIN MAY BE A RESULT AF ASHERMAN'S SYNDROME.

    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 UNKNOWN Required Intervention