BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 20603167 · Received November 4, 2024

    Report

    Report Number
    2210968-2024-11461
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    September 29, 2023
    Report Date
    April 14, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (B)(4) IS NOT AVAILABLE. CITATION: ARCHIVES OF GYNECOLOGY AND OBSTETRICS (2024) 310:1121¿1129. HTTPS://DOI.ORG/10.1007/S00404-023-07224-0.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THIS DEVICE IS NOT RELATED TO THE EVENT. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: SHOULD IT REALLY BE CALLED A HEROIC CERCLAGE? THE OBSTETRICAL RESULTS OF EMERGENCY LATE SECOND-TRIMESTER CERCLAGE COMPARED WITH EARLY HISTORY-INDICATED ELECTIVE CERCLAGE: A RETROSPECTIVE TRIAL. THE OBJECTIVE OF THIS RETROSPECTIVE COHORT STUDY WAS, THEREFORE, TO COMPARE THE OBSTETRICAL OUTCOMES OF EMERGENCY CERCLAGE VERSUS ELECTIVE CERCLAGE. BETWEEN DECEMBER 2008 AND NOVEMBER 2021, 215 WOMEN WITH A SINGLETON PREGNANCY WHO UNDERWENT CERVICAL CERCLAGE WERE INCLUDED IN THIS STUDY. WOMEN WHO UNDERWENT EMERGENCY CERVICAL CERCLAGE (N=32; MEAN AGE OF 30.9±5 YEARS; MEAN BMI OF 29.2±7.3 KG/M2) DUE TO PAINLESS DILATATION IN THE SECOND TRIMESTER WERE COMPARED WITH WOMEN WHO UNDERWENT ELECTIVE CERCLAGE (N=183; MEAN AGE OF 32.4±5.5 YEARS; MEAN BMI OF 26.2±5.8 KG/M2). MONOFILAMENT MERSILENE TAPE (ETHICON©, JOHNSON & JOHNSON INTERNATIONAL, NJ, US) WAS USED TO SUTURE THE CERVIX. THE CERCLAGE SUTURE WAS REMOVED AT 36¿37 WEEKS OF GESTATION, OR EARLIER IN CASES OF THREATENED PRETERM LABOR. REPORTED COMPLICATION INCLUDE DELIVERY DURING THE EXTREME PREMATURITY PERIOD (24¿28 GESTATIONAL WEEKS) (N=6), CERVICAL LACERATION (N=8), PREMATURE VIABLE DELIVERY PRIOR TO 32 GESTATIONAL WEEKS (N=12), PREMATURE VIABLE DELIVERY PRIOR TO 34 GESTATIONAL WEEKS (N=18), PREMATURE VIABLE DELIVERY PRIOR TO 37 GESTATIONAL WEEKS (N=65), CONTRACTION OR TENSION OVER THE CERCLAGE SUTURE (N=25), PRETERM PREMATURE RUPTURE OF THE MEMBRANES (N=4), OBSTETRICAL INDICATION FOR LABOUR INDUCTION (N=10), CERVICAL FENESTRATION OF THE CERCLAGE (N=4), CHORIOAMNIONITIS (N=7), AND FAILURE OF THE FIRST CERCLAGE PROCEDURE (N=2). IN CONCLUSION, ALTHOUGH THERE ARE MUCH LESS FAVOURABLE CIRCUMSTANCES, EMERGENCY CERCLAGE IS A SAFE PROCEDURE WITH COMPARABLE OBSTETRICAL OUTCOMES TO ELECTIVE CERCLAGE. PATIENT SELECTION AND EXPERIENCED MEDICAL TEAM MAY PLAY A SIGNIFICANT ROLE IN THOSE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625663 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention