BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16077031 · Received December 30, 2022

    Report

    Report Number
    2210968-2022-10768
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    October 20, 2022
    Report Date
    January 11, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-10765, 2210968-2022-10766, 2210968-2022-10767. CITATION: HTTPS://DOI.ORG/10.21608/EBWHJ.2022.163890.1203.

    Description of Event or Problem · 0

    TITLE: EMBRYO REDUCTION TO TWINS (ERTT) VERSUS CERCLAGE IN TRIPLETS IN WOMEN WITH NORMAL CERVICAL PARAMETERS: A RETROSPECTIVE STUDY. THE AIM OF THIS STUDY WAS TO COMPARE THE EFFICACY AND SAFETY OF ERTT TO CERCLAGE IN TRIPLET PREGNANCY. IN THIS RETROSPECTIVE STUDY, FILES OF 266 PATIENTS WERE EXAMINED. ELIGIBLE PATIENTS MANAGED BY ERTT (N=120) WERE ALLOCATED INTO STUDY GROUP WHILE PATIENTS MANAGED BY CERCLAGE (N=121) WERE ALLOCATED INTO CONTROL GROUP. EMBRYO REDUCTION WAS DONE BY OOCYTE ASPIRATION NEEDLE BEFORE 10TH WEEK. CERCLAGE WAS DONE AT 14-16 WEEKS. OBSTETRICAL AND NEONATAL ADVERSE OUTCOMES WERE ASSESSED IN BOTH GROUPS. CERCLAGE OPERATION: WAS DONE UNDER GENERAL ANESTHESIA USING MCDONALD'S PROCEDURE APPLYING 4 BITES TO CERVIX WITH KNOT APPLIED POSTERIORLY. THE THREAD USED WAS EITHER SILK 1/0 OR DOUBLE NEEDLE MERSILENE 1/0 (ETHICON) REPORTED COMPLICATIONS INCLUDED ABORTION (N=33), VAGINAL BLEEDING (N=11) IN CONCLUSION EMBRYO REDUCTION TO TWINS (ERTT) PROCEDURES IMPROVED OBSTETRICAL AND NEONATAL OUTCOMES IN TRIPLET PREGNANCIES COMPARED TO CONSERVATIVE MANAGEMENT WITH CERCLAGE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425123 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other