BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 20658193 · Received November 11, 2024

    Report

    Report Number
    2210968-2024-11824
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    November 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HELIYON 10. PAGES: 1-10. HTTPS://DOI.ORG/10.1016/J.HELIYON.2024.E32923.

    Description of Event or Problem · 0

    TITLE: NOMOGRAM-BASED RISK ASSESSMENT FOR EMERGENCY CERVICAL CERCLAGE FAILURE IN PATIENTS WITH CERVICAL INSUFFICIENCY. THE AIM OF THIS STUDY WAS TO IDENTIFY THE RISK FACTORS ASSOCIATED WITH CERCLAGE FAILURE AND DEVELOP A PREDICTIVE NOMOGRAM MODEL FOR PATIENTS WITH CERVICAL INSUFFICIENCY UNDERGOING EMERGENCY CERVICAL CERCLAGE. CLINICAL DATA AND NEONATAL OUTCOMES FROM 200 PATIENTS DIAGNOSED WITH CERVICAL INSUFFICIENCY WHO UNDERWENT EMERGENCY CERVICAL CERCLAGE AT JINAN MATERNAL AND CHILD HEALTH HOSPITAL BETWEEN JANUARY 1, 2016 AND MAY 31, 2023 WERE RETROSPECTIVELY ANALYZED. THE SUCCESS OF THE PROCEDURE WAS INDICATED BY THE SUCCESSFUL DISCHARGE OF THE INFANT, AND THE PATIENTS WERE DIVIDED INTO THE SUCCESS (N = 149) AND FAILURE GROUPS (N = 51). THE BLADDER WAS PUSHED UPWARD, AND A MERSILENE SUTURE WAS APPLIED AROUND THE CERVIX, AVOIDING THE VASCULAR BUNDLES AT THE 3 AND 9 O¿CLOCK POSITIONS. THE REPORTED COMPLICATIONS INCLUDED CHORIOAMNIONITIS (N=52), MATERNAL SEPSIS (N=26), CERVICAL LACERATION (N=26) AND PRETERM PREMATURE RUPTURE OF MEMBRANES (N=63). IN CONCLUSIONS, THIS STUDY SUCCESSFULLY IDENTIFIED RISK FACTORS ASSOCIATED WITH EMERGENCY CERVICAL CERCLAGE FAILURE IN PATIENTS WITH CERVICAL INSUFFICIENCY AND DEVELOPED A PREDICTIVE NOMOGRAM MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1643218 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other