BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE CATHETER UNKNOWN PRODUCT

    MDR report key: 8133871 · Received December 5, 2018

    Report

    Report Number
    2210968-2018-77529
    Event Type
    Injury
    Date Received
    December 5, 2018
    Report Date
    November 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: CONTRACEPTION 87 (2013) 409¿415; DOI: HTTP://DX.DOI.ORG/10.1016/J.CONTRACEPTION.2012.11.004 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: FIVE-YEAR FOLLOW-UP OF LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM VERSUS THERMAL BALLOON ABLATION FOR THE TREATMENT OF HEAVY MENSTRUAL BLEEDING: A RANDOMIZED CONTROLLED TRIAL" AUTHOR(S): AGNALDO L. SILVA-FILHO, FRANCISCO DE A.N. PEREIRA, SÉRGIO S. DE SOUZA, LUCIANO F. LOURES, ANA PAULA C. ROCHA, CAROLINA N. VALADARES, MÁRCIA M. CARNEIRO, RUBENS L.C. TAVARES, AROLDO F. CAMARGOS CITATION: CONTRACEPTION 87 (2013) 409¿415; DOI: HTTP://DX.DOI.ORG/10.1016/J.CONTRACEPTION.2012.11.004. THE AIM OF THIS PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL WAS TO COMPARE THE RESULTS OF WOMEN SUBMITTED TO LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM (LNG-IUS) OR THERMAL BALLOON ABLATION (TBA) FOR THE TREATMENT OF HEAVY MENSTRUAL BLEEDING (HMB) AFTER 5-YEAR FOLLOW-UP USING AS END POINTS HEMOGLOBIN LEVELS, BLEEDING PATTERNS, PATIENT QUALITY OF LIFE AND SATISFACTION RATES. BETWEEN JAN2005 AND MAR2007, 84 FEMALE PATIENTS WITH HMB WERE RANDOMIZED INTO TWO TREATMENT GROUPS: LNG-IUS (N=30; AGE OF 42±0.7 YEARS) AND TBA (N=28; AGE OF 43.4±0.7 YEARS). IN TBA GROUP, THE PROCEDURE WAS PERFORMED WITH GYNECARE THERMACHOICE UTERINE BALLOON THERAPY SYSTEM. DURING A 5-YEAR FOLLOW-UP, COMPLICATIONS INCLUDED TREATMENT FAILURE (N=6) FOR WHICH THEY UNDERWENT HYSTERECTOMY, AND INCREASED MENSTRUAL BLOOD LOSS (N=45.5%). FIVE-YEAR FOLLOW-UP OF HMB TREATMENT WITH LNG-IUS WAS ASSOCIATED WITH HIGHER EFFICACY AND SATISFACTION RATINGS COMPARED TO TBA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975658 THERMACHOICE CATHETER UNKNOWN PRODUCT DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention