BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22579277 · Received July 23, 2025

    Report

    Report Number
    2210968-2025-08530
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    January 1, 2025
    Report Date
    June 8, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: INT J ACAD MED PHARM. 2025; 7 (3); 748-753. PLEASE SEE ATTACHED ARTICLE.

    Description of Event or Problem · 0

    TITLE: COMPARATIVE STUDY ON THE EFFICACY OF ANTIBACTERIAL (TRICLOSAN-COATED) SUTURES VERSUS CONVENTIONAL SUTURES IN REDUCING SURGICAL SITE INFECTIONS FOLLOWING ABDOMINAL SURGERY. THE AIM OF THIS STUDY IS TO COMPARES THE EFFECTIVENESS OF TRICLOSAN-COATED ANTIBACTERIAL SUTURES (VICRYL PLUS) WITH CONVENTIONAL NON- ANTIBACTERIAL SUTURES (VICRYL) IN REDUCING THE INCIDENCE AND SEVERITY OF POSTOPERATIVE SSIS. BETWEEN JUNE 2022¿JUNE 2024, A TOTAL OF 280 PATIENTS WERE ENROLLED AND RANDOMIZED INTO TWO GROUPS OF 140 EACH. THE STUDY EVALUATED FACTORS INCLUDING AGE, SEX, LEVEL OF WOUND CONTAMINATION, URGENCY OF SURGERY, TYPE OF OPERATIVE PROCEDURE, AND PATIENT CONDITIONS SUCH AS STEROID USE. REPORTED COMPLICATIONS ARE: VICRYL PLUS SUTURES (ETHICON) SSI (SURGICAL SITE INFECTION) RATE (N=29%). VICRYL SUTURES (ETHICON) SSI (SURGICAL SITE INFECTION) RATE (N=60%). IN CONCLUSION, TRICLOSAN-COATED VICRYL PLUS SUTURES DEMONSTRATE A CONSISTENT, ALBEIT STATISTICALLY NONSIGNIFICANT, REDUCTION IN SSI RATES ACROSS MULTIPLE PARAMETERS. THE BENEFIT APPEARS MOST PRONOUNCED IN HIGH-CONTAMINATION (DIRTY) CASES, SUGGESTING THEIR POTENTIAL USE IN SELECT HIGH-RISK PATIENTS. FURTHER LARGE-SCALE, MULTICENTER STUDIES WITH ENHANCED STATISTICAL POWER ARE RECOMMENDED TO ESTABLISH DEFINITIVE GUIDELINES ON THE ROUTINE USE OF ANTIBACTERIAL SUTURES IN ABDOMINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000884 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other