BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 20675467 · Received November 13, 2024

    Report

    Report Number
    2210968-2024-11960
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    January 1, 2022
    Report Date
    November 13, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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: AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY (SUPPLEMENT TO JANUARY 2022): S544. AJOG.ORG.

    Description of Event or Problem · 0

    TITLE: THE ASSOCIATION OF GROUP B STREPTOCOCCUS COLONIZATION WITH CERCLAGE AND SUTURE MATERIAL THE OBJECTIVE OF THE SINGLE-CENTER RETROSPECTIVE COHORT STUDY WAS TO COMPARE GROUP B STREPTOCOCCUS (GBS) COLONIZATION RATES IN WOMEN WITH AND WITHOUT TRANSVAGINAL CERCLAGE, AS WELL AS AMONG WOMEN WITH A CERCLAGE USING MERSILENE VERSUS PROLENE SUTURE. A TOTAL OF 216 WOMEN WERE INCLUDED IN THE STUDY. EACH WOMAN UNDERGOING MCDONALD CERCLAGE WITH MERSILENE OR PROLENE SUTURE (CERCLAGE GROUP) FROM 1/1/2017 - 12/31/2019 WAS MATCHED WITH A WOMAN WITHOUT A CERCLAGE BY DELIVERY DATE (CONTROL GROUP). REPORTED COMPLICATIONS PER SUTURE TYPE INCLUDE: MERSILENE SUTURE (ETHICON): - GROUP B STREPTOCOCCUS (GBS) POSITIVE (N=23). TREATMENT: NOT REPORTED. - CHORIOAMNIONITIS (N=14). TREATMENT: NOT REPORTED. - MATERNAL SEPSIS (N=1). TREATMENT: NOT REPORTED. - NEONATAL SEPSIS (N=3). TREATMENT: NOT REPORTED. PROLENE SUTURE (ETHICON).: - GROUP B STREPTOCOCCUS (GBS) POSITIVE (N=8). TREATMENT: NOT REPORTED. - CHORIOAMNIONITIS (N=9). TREATMENT: NOT REPORTED. - NEONATAL SEPSIS (N=3). TREATMENT: NOT REPORTED. IN CONCLUSION, THE PRESENCE OF A CERCLAGE AND CERCLAGE SUTURE TYPE ARE NOT ASSOCIATED WITH DIFFERING RATES OF GBS COLONIZATION. WHETHER CERCLAGE CHANGES THE VAGINAL ENVIRONMENT IN OTHER WAYS WHICH COULD CONTRIBUTE TO INFLAMMATION OR DYSBIOSIS WARRANTS FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105704 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other