BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23075870 · Received September 17, 2025

    Report

    Report Number
    2210968-2025-10593
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    September 3, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    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 TURK GER GYNECOL ASSOC. 2025 SEP 3;26(3):180-189. HTTPS://DOI.ORG/10.4274/JTGGA.GALENOS.2025.2024-11-4 EPUB 2025 JUL 31. PMID: 40741800; PMCID: PMC12406971.

    Description of Event or Problem · 0

    TITLE: RETROSPECTIVE EVALUATION OF TRANSVAGINAL CERVICAL CERCLAGE CASES IN A TERTIARY REFERENCE CENTER: COMPARISON OF INDICATIONS AND SUTURE MATERIALS. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE OBSTETRIC AND NEONATAL OUTCOMES IN PREGNANCIES WITH CC ACCORDING TO CERCLAGE INDICATION AND SUTURE MATERIALS USED. BETWEEN JANUARY 1, 2004 AND DECEMBER 31, 2023, A TOTAL OF 173 TRANSVAGINAL CC PROCEDURES WERE PERFORMED DURING THE STUDY. DIVIDED INTO THREE GROUPS; 103 IN THE HICC, 45 IN THE UICC AND 25 IN THE PEICC GROUP. WITH MEAN AGE OF 32 (29-35),33.5 (30-37.5) AND 33 (28.5-34.5) RESPECTIVELY. PROLENE SUTURE (ETHICON, JOHNSON & JOHNSON, NEW JERSEY, USA) AND MERSILENE TAPE (5-0 WHITE 1X18¿S-14 DOUBLE ARMED, ETHICON, JOHNSON & JOHNSON, NEW JERSEY, USA) WERE USED IN ALL GROUPS. REPORTED COMPLICATIONS: PROLENE SUTURE(ETHICON) -NEONATAL INFECTION (N=11) TREATMENT: NOT REPORTED MERSILENE TAPE (ETHICON) -NEONATAL INFECTION (N=4) TREATMENT: NOT REPORTED. IN CONCLUSIONS, PEICC HAD WORSE PERINATAL OUTCOMES COMPARED TO HICC AND UICC PROCEDURES. CC INDICATION WAS THE MAJOR DETERMINANT OF PERINATAL OUTCOME IN THIS COHORT WHILE SUTURE MATERIAL HAD NO SIGNIFICANT EFFECT ON PERINATAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648470 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other