BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 23692797 · Received December 2, 2025

    Report

    Report Number
    2210968-2025-13359
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    July 9, 2025
    Report Date
    December 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. 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 (01) GTIN IS NOT AVAILABLE. CITATION: AM J OBSTET GYNECOL. 2025 JUL 9:S0002-9378(25)00427-2. HTTPS://DOI.ORG/10.1016/J.AJOG.2025.06.049 EPUB AHEAD OF PRINT. PMID: 40645472; PMCID: PMC12510710.

    Description of Event or Problem · 0

    TITLE: EFFECT OF TRANSABDOMINAL VERSUS TRANSVAGINAL CERCLAGE ON PRETERM BIRTH AND NEONATAL OUTCOMES AMONG PATIENTS WITH A HISTORY OF CERVICAL INSUFFICIENCY. THE OBJECTIVE OF THE STUDY :1) TO ESTIMATE THE EFFECT OF TRANSABDOMINAL CERCLAGE VS TRANSVAGINAL CERCLAGE ON EARLY PRETERM DELIVERY (<34 WEEKS) AMONG PATIENTS WITH HISTORY OF CERVICAL INSUFFICIENCY AT A QUATERNARY CARE CENTER; 2) TO ESTIMATE THE EFFECT WITHIN A SUBGROUP OF PATIENTS WITHOUT HISTORY OF FAILED TRANSVAGINAL CERCLAGE; AND 3) TO DESCRIBE ASSOCIATED COMPLICATIONS OF PLACEMENT AND DELIVERY AND NEONATAL OUTCOMES. BETWEEN JANUARY 1, 2001, AND FEBRUARY 28, 2021, A TOTAL OF 188 PATIENTS WERE INCLUDED IN THE STUDY. CERCLAGE TYPE DIVIDED INTO TWO: TVC (N=101) AND THE MEAN AGE AT CERCLAGE PLACEMENT (32.3) YEARS WHILE TAC (N=87). WITH (34.9) YEARS. MERSILENE TAPE (ETHICON) WAS USED IN THE STUDY. REPORTED COMPLICATIONS: MERSILENE TAPE (ETHICON). -BLOOD LOSS >1 L (11% OVERALL). TREATMENT: NOT REPORTED. - UTERINE DEHISCENCE (N=2). TREATMENT: NOT REPORTED. - UTERINE RUPTURE (N=1). TREATMENT: NOT REPORTED. - CERVICAL LACERATIONS (N=2). TREATMENT: NOT REPORTED. -NICU ADMISSION IN THE TVC GROUP DUE TO PREMATURITY (N=32)). TREATMENT: NOT REPORTED. -TAC GROUP ADMISSION CAUSE OF RESPIRATORY DISTRESS (N=31). TREATMENT: NOT REPORTED. -COMPLICATIONS OF PROCEDURE (N=3). TREATMENT: NOT REPORTED. IN CONCLUSIONS, ABOUT EFFICACY AMONG PATIENTS WITHOUT HISTORY OF FAILED TRANSVAGINAL CERCLAGE ARE LIMITED BY SMALL SAMPLE SIZE. FURTHER RESEARCH IS NECESSARY TO UNDERSTAND WHETHER THE BENEFITS OF TRANSABDOMINAL CERCLAGE IN SUBGROUPS OF PATIENTS OUTWEIGH RISKS OF ABDOMINAL SURGERY AND CESAREAN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913235 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention