BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE CATHETER UNKNOWN PRODUCT

    MDR report key: 8131804 · Received December 4, 2018

    Report

    Report Number
    2210968-2018-77506
    Event Type
    Injury
    Date Received
    December 4, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: BJOG. 2013; 120 (SUPPL 1): 493 ¿ 494. DOI: HTTP://DX.DOI.ORG/10.1111/1471-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE : MENORRHAGIA AND SURGICAL TREATMENT: THE CLINICAL EFFECTIVENESS OF NOVASURE VERSUS THERMACHOICE. THE OBJECTIVE OF THE STUDY WAS TO AUDIT THE PRACTICE OF SURGICAL ENDOMETRIAL ABLATION TECHNIQUES AND EVALUATE THE EFFECTIVENESS OF SURGICAL TECHNIQUES IN THE TREATMENT OF MENORRHAGIA. THIS IS A RETROSPECTIVE STUDY GAINING CLINICAL INFORMATION FROM PATIENT NOTES OF ALL WOMEN WHO UNDERWENT THE SPECIFIED TECHNIQUES BETWEEN 2009 AND 2011. A TOTAL OF 100 PATIENTS UNDERWENT EITHER THERMACHOICE BALLOON ABLATION (ETHICON; 88 PATIENTS) OR NOVASURE BIPOLAR RADIOFREQUENCY ABLATION FOR BENIGN CAUSES OF MENORRHAGIA. IN THE THERMACHOICE BALLOON ABLATION GROUP, REPORTED COMPLICATIONS INCLUDED CERVICAL STENOSIS, ADHESIONS, FISTULA, AND DYSMENORRHEA. THE STUDY DEMONSTRATES A GREATER REDUCTION IN MENSTRUAL BLOOD LOSS IN THERMACHOICE TECHNIQUES WHEN COMPARE TO NOVASURE PROCEDURES UNDERTAKEN IN THE ROYAL GLAMORGAN HOSPITAL. HOWEVER THERMACHOICE PROCEDURES LED TO AN INCREASED HYSTERECTOMY RATE AND DYSMENORRHOEA RATE WHEN COMPARED TO NOVASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967617 THERMACHOICE CATHETER UNKNOWN PRODUCT DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention