BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 23612203 · Received November 20, 2025

    Report

    Report Number
    2210968-2025-13050
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    August 8, 2024
    Report Date
    November 20, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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: TAIWAN J OBSTET GYNECOL. 2024 NOV;63(6):941-943. HTTPS://DOI.ORG/10.1016/J.TJOG.2024.08.003. PMID: 39482009.

    Description of Event or Problem · 0

    TITLE: EROSIVE STITCHES OF CERVICAL CERCLAGE AS A FACTOR OF ABNORMAL UTERINE BLEEDING: A REPORT OF TWO CASES. THIS ARTICLE PRESENTS THE CASE OF A 53-YEAR-OLD FEMALE PATIENT EXPERIENCED FAILED MACDONALD CERVICAL CERCLAGE BECAUSE OF THE SHORT CERVIX, WHICH CAUSED A PREVIABLE PRETERM DELIVERY AT 21 WEEKS OF GESTATION IN 2003, FOLLOWED BY ABDOMINAL CERCLAGE PLACEMENT WITH TAPE DURING THE NEXT PREGNANCY AT 18 WEEKS OF GESTATION IN 2005. THE MERSILENE TAPE WAS LEFT IN PLACE FOR FURTHERMORE PREGNANCIES. AND 40-YEAR-OLD FEMALE PATIENT . SHE THEN RECEIVED TWO SURGERIES OF MCDONALD'S CERCLAGES IN 2015 AND 2018. REPORTED COMPLICATIONS ARE : MERSILENE TAPE (ETHICON) 53-YEAR-OLD FEMALE -INTERMENSTRUAL BLEEDING (N=1) TREATMENT : REMOVED THE RESIDUAL CERCLAGE TAPE BY HYSTERSCOPY. IN CONCLUSION, A COMPREHENSIVE HISTORY IS CRUCIAL TO AUB EVALUATION. TAKING BOTH OBSTETRIC AND GYNECOLOGIC HISTORY THOROUGHLY, ESPECIALLY A PREVIOUS HISTORY OF IATROGENIC PROCESSES, SUCH AS INTRAUTERINE DEVICE PLACEMENT OR RETAINED CERCLAGE STITCHES, IS IMPORTANT. ADDITIONALLY, CERCLAGE REMOVAL DURING THE POSTPARTUM FOLLOW-UP PERIODS IS MANDATED IF THE PATIENT DOES NOT HAVE FUTURE REPRODUCTIVE PLANS TO REDUCE THE AUB OR INFECTION BECAUSE OF THE POSSIBILITY OF STITCH MIGRATION AND EROSION IN THE FUTURE. THE MIGRATION OF CERCLAGE MERSILENE TAPE CAN INDUCE AUB, AND HYSTEROSCOPY PROVES TO BE AN ACCURATE METHOD FOR IDENTIFYING AND REMOVING THE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309317 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention