BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 18858126 · Received March 7, 2024

    Report

    Report Number
    2210968-2024-02640
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    January 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. AN ATTEMPT HAS BEEN 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. H6 CLINICAL CODE: E2402 ¿ CERVICAL DILATATION OF AT LEAST 1 CM OR MORE, PREMATURE RUPTURE OF MEMBRANES, CHORIOAMNIONITIS, PRETERM BIRTHS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2024-02637, 2210968-2024-02638, 2210968-2024-02639 AND 2210968-2024-02640. CITATION: ADV RES OBSTET GYNAECOL. 2023;1(2):E2306. DOI: 10.62093/E2306. PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: EVALUATION OF THE IMPACT OF SECOND TRIMESTER CERVICAL CERCLAGE ON PERINATAL OUTCOMES: THE EXPERIENCE OF A SINGLE TERTIARY CENTRE. THE AIM OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE OUTCOMES OF PATIENTS WHO UNDERWENT CERVICAL CERCLAGE AND THE CONTRIBUTION OF THIS PROCEDURE TO THE CONTINUATION OF PREGNANCY. BETWEEN OCTOBER 2021 AND SEPTEMBER 2022, A TOTAL OF 58 PATIENTS WITH A MEAN AGE OF 29.7±5.3 (MIN-MAX: 18-43) YEARS, DIAGNOSED WITH CERVICAL INSUFFICIENCY WHO UNDERWENT CERCLAGE BETWEEN THE 14TH AND 25TH WEEK OF PREGNANCY, WERE INCLUDED IN THE STUDY. PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE INDICATION FOR CERCLAGE: ELECTIVE CERCLAGE (WITH INDICATION FOR MEDICAL HISTORY; N=23) AND EMERGENCY CERCLAGE (WITH INDICATION FOR PHYSICAL EXAMINATION AND ULTRASOUND; N=35).THE CERVICAL SUTURES WERE PERFORMED IN THE LITHOTOMY POSITION WITH MERSILENE OR PROLENE SUTURES AS CLOSE AS POSSIBLE TO THE INNER CERVIX UNDER SPINAL OR GENERAL ANESTHESIA. THE CERCLAGE WAS REMOVED AT 37 WEEKS UNLESS SPONTANEOUS LABOR, RUPTURE OF MEMBRANES OR THE NEED FOR PRETERM DELIVERY OCCURRED. REPORTED COMPLICATIONS INCLUDE PELVIC PAIN (N=16) AND BLEEDING (N=6) WERE OBSERVED DURING APPLICATION; CERVICAL DILATATION OF AT LEAST 1 CM OR MORE (N=18), PREMATURE RUPTURE OF MEMBRANES (N=10), HEMORRHAGE (N=10), CHORIOAMNIONITIS (N=1), MISCARRIAGES (N=15.1%), AND PRETERM BIRTHS (N=34%). IN CONCLUSION, EARLY DIAGNOSIS AND INTERVENTION OF CERVICAL INSUFFICIENCY THROUGH HISTORY, PHYSICAL EXAMINATION AND TRANSVAGINAL CERVICAL LENGTH MEASUREMENT MAY IMPROVE PREGNANCY AND NEONATAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881619 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other