BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 20664863 · Received November 12, 2024

    Report

    Report Number
    2210968-2024-11847
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    June 19, 2024
    Report Date
    November 12, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. 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 (01)GTIN IS NOT AVAILABLE. CITATION: J. PERINAT. MED. 2024; 52(7): 706¿711. HTTPS://DOI.ORG/10.1515/JPM-2024-0049.

    Description of Event or Problem · 0

    TITLE: EXPECTANT MANAGEMENT VS. CERCLAGE IN CASES WITH PROLAPSED OR VISIBLE MEMBRANES IN THE SECOND TRIMESTER: IS 24 WEEKS GESTATION THRESHOLD CRITICAL? THE AIM OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE OUTCOMES OF RESCUE CERCLAGE PLACEMENT WITH CONSERVATIVE MANAGEMENT IN PATIENTS WITH VISIBLE OR PROLAPSED FETAL MEMBRANES BEYOND THE EXTERNAL CERVICAL OS, AT 18¿28 WEEKS OF GESTATION. BETWEEN 1ST JANUARY 2017 AND 31ST DECEMBER 2022, A TOTAL OF 97 PREGNANT WOMEN WERE INCLUDED IN THE STUDY. THE INCLUSION CRITERIA WERE: GESTATIONAL AGE BETWEEN 18TH AND 27+6 WEEKS; VIABLE SINGLETON PREGNANCIES; AND CERVICAL DILATATION =3 CM WITH PROLAPSED FETAL MEMBRANES. PATIENT GROUPS WERE: CERCLAGE GROUP N=76 (MEAN AGE WAS 29.3 ± 5.4 YEARS); AND NO-CERCLAGE GROUP N=21 (MEAN AGE WAS 29.4 ± 6 YEARS). FOR CERVICAL CERCLAGE, THE PATIENT WAS PLACED IN TRENDELENBURG POSITION WITH MCDONALD¿S METHOD BY USING MERSILENE TAPE (MERSILENE TAPE, 40 CM, ETHICON INC., RARITAN, NJ, USA) AFTER CERVICAL IRRIGATION WITH BETADINE SOLUTION UNDER GENERAL ANESTHESIA. REPORTED COMPLICATIONS INCLUDE SIGNS OF CHORIOAMNIONITIS DURING FOLLOW-UP (N=20), MATERNAL SEPSIS (N=3), AND PREMATURE RUPTURE OF MEMBRANES (N=32). IN CONCLUSION, CERVICAL CERCLAGE APPLIED BEFORE AND AFTER 24 WEEKS (UNTIL 27+6 WEEKS) INCREASED TAKE HOME BABY RATE IN WOMEN WITH VISIBLE OR PROLAPSED FETAL MEMBRANES WITHOUT INCREASING ADVERSE MATERNAL OUTCOME WHEN COMPARED WITH NO-CERCLAGE GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542377 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other