BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 20558748 · Received October 29, 2024

    Report

    Report Number
    2210968-2024-11199
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    November 15, 2023
    Report Date
    October 29, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. CITATIONS: AM J OBSTET GYNECOL. PAGES: 1-11. HTTP://DX.DOI.ORG/10.1016/J.AJOGMF.2023.101227.

    Description of Event or Problem · 0

    TITLE: FAVORABLE SURGICAL AND OBSTETRICAL OUTCOMES IN PRE AND POSTCONCEPTIONAL LAPAROSCOPIC ABDOMINAL CERCLAGE: A LARGE MULTICENTER COHORT STUDY. THIS STUDY AIMED TO ASSESS SURGICAL AND OBSTETRICAL OUTCOMES IN PATIENTS WITH PRE- AND POSTCONCEPTIONAL LAPAROSCOPIC ABDOMINAL CERCLAGE PLACEMENT. A RETROSPECTIVE MULTICENTER COHORT STUDY WITH CONSECUTIVE INCLUSION OF ALL ELIGIBLE PATIENTS FROM 1997 ONWARD IN THE DUTCH COHORT (104 PATIENTS) AND FROM 2007 ONWARD IN THE BOSTON COHORT (169 PATIENTS) WAS CONDUCTED. IN BOTH CENTERS, LAC PLACEMENT WAS ONLY PERFORMED BY EXPERIENCED LAPAROSCOPIC SURGEONS. THE SURGICAL PROCEDURES MEDIALLY TO THE UTERINE VESSELS, A 5-MM WIDE MERSILENE TAPE SUTURE WAS PLACED AT THE CERVICOCORPOREAL JUNCTION. AFTER DETACHING THE NEEDLES, 7 INTRACORPOREALLY TIED KNOTS WERE PLACED ANTERIORLY. A 2-0 SILK SUTURE WAS USED TO TIE THE ENDS OF THE MERSILENE TAPE TO THE LOWER UTERINE SEGMENT. FINALLY, A MONOCRYL SUTURE 2-0 (ETHICON, RARITAN, NJ) WAS USED TO CLOSE THE VESICOUTERINE PERITONEUM. APPENDIX 1 INCLUDES THE DETAILS OF THE SURGICAL PROCEDURE. THE REPORTED COMPLICATIONS INCLUDED UTERINE PERFORATION (N=6) AND SUPERFICIAL INFECTION OF THE ABDOMINAL WOUND (N=1). IN CONCLUSION, PRE- AND POSTCONCEPTIONAL LAPAROSCOPIC ABDOMINAL CERCLAGE IS A SAFE PROCEDURE WITH FAVORABLE OBSTETRICAL OUTCOMES IN PATIENTS WITH INCREASED RISK OF CERVICAL INCOMPETENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929837 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention