BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22017354 · Received May 14, 2025

    Report

    Report Number
    2210968-2025-05328
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    June 21, 2024
    Report Date
    May 13, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. CITATION: J MAXILLOFAC ORAL SURG. 2025 APR;24(2):557-568. HTTPS://DOI.ORG/10.1007/S12663-024-02249-7. EPUB 2024 JUN 21. PMID: 40182450; PMCID: PMC11961785.

    Description of Event or Problem · 0

    TITLE: COMPARING THE CLINICAL AND MICROBIOLOGICAL EFFECTS OF ANTIBACTERIAL-COATED VICRYL SUTURE AND NON-COATED VICRYL SUTURE AFTER MINOR ORAL SURGICAL PROCEDURES. THIS STUDY AIMED TO COMPARE THE ANTIBACTERIAL EFFECT OF VICRYL PLUS SUTURE (POLYGLACTIN 910 COATED WITH TRICLOSAN) AND NON-COATED VICRYL SUTURE BY ANALYSING CLINICAL AND MICROBIOLOGICAL DIFFERENCES AND ASSESSING THE ISOLATES THROUGH ANTIBIOTIC SENSITIVITY TESTING. BETWEEN JUNE 2021 TO JUNE 2022, A TOTAL OF 27 PATIENTS WERE RECRUITED FOR THIS STUDY THAT AIMED TO EVALUATE THE CLINICAL AND MICROBIOLOGICAL EFFECTS OF ANTIBACTERIAL-COATED VICRYL PLUS AND NON-COATED VICRYL SUTURES IN SUBJECTS USING A SPLIT MOUTH TECHNIQUE AFTER MINOR ORAL SURGICAL PROCEDURES. REPORTED COMPLICATIONS ARE THE FOLLOWING: PATIENT 24 (N=1). VICRYL SUTURE (ETHICON): - EXPERIENCED MORE DISCOMFORT WITH VICRYL SUTURE THAN VICRYL PLUS SUTURE. - BLEEDING AND INFLAMMATION (SURGICAL SITE INFECTION). TREATMENT: NOT SPECIFIED, BUT ARTICLE STATED "ALL PATIENTS WERE GIVEN POSTOPERATIVE INSTRUCTIONS ON MAINTAINING ORAL HYGIENE. POSTOPERATIVE ANTIBIOTICS AND ANTI-INFLAMMATORY AGENTS WERE PRESCRIBED." IN CONCLUSION, THIS STUDY DEMONSTRATE THAT THE USE OF VICRYL PLUS SUTURES DID NOT DECREASE THE INCIDENCE OF SURGICAL SITE INFECTION FOLLOWING MINOR ORAL SURGERY. BASED ON VAS, PATIENTS REPORTED HIGHER INCIDENCE OF PAIN AT THE SUTURE SITES OF VICRYL PLUS SUTURES AS COMPARED TO MILD DISCOMFORT WITH VICRYL SUTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881804 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention