BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22195664 · Received June 12, 2025

    Report

    Report Number
    2210968-2025-06712
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    January 5, 2024
    Report Date
    June 12, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 CRANIOMAXILLOFAC SURG. 2024 MAR;52(3):310-315. HTTPS://DOI.ORG/10.1016/J.JCMS.2024.01.004. EPUB 2024 JAN 5. PMID: 38212164.

    Description of Event or Problem · 0

    TITLE: COMPREHENSIVE REPAIR OF THE ALVEOLAR CLEFT USING CORTICAL AND CANCELLOUS BONE LAYERS: A RETROSPECTIVE STUDY. THE PURPOSE OF THIS STUDY WAS TO PROPOSE A PROTOCOL FOR THE COMPREHENSIVE TREATMENT OF ALVEOLAR CLEFT AND TO EVALUATE ITS CLINICAL RESULTS WITH A RETROSPECTIVE ANALYSIS. BETWEEN JANUARY 1, 2020 AND DECEMBER 31, 2021, A TOTAL OF 54 PATIENTS (29 MALE AND 25 FEMALE) WITH UNILATERAL ALVEOLAR CLEFTS WHO UNDERWENT CTAC WERE INCLUDED IN THE STUDY. THE AVERAGE PATIENT AGE AT THE TIME OF THE OPERATION WAS 10.3 PLUS OR MINUS 2.1 YEARS (RANGE 9¿17 YEARS). THE WOUND WAS RINSED, A RELAXING INCISION WAS MADE DISTALLY IF NECESSARY, AND THE GINGIVA WAS SECURED WITH 3-0 VICRYL ABSORBABLE SUTURES UNDER NO TENSION. THE AVERAGE POSTOPERATIVE FOLLOW-UP TIME WAS 14.6 PLUS OR MINUS 2.2 MONTHS. REPORTED COMPLICATIONS INCLUDE: DEHISCENCE OF THE SOFT-TISSUE FLAP COVERING THE GRAFT WAS FOUND AT 1 WEEK AFTER SURGERY AND EXAMINATION REVEALED PARTIAL SUTURE DEHISCENCE WITH A SMALL FISSURE (N=2) TREATMENT: THE WOUND WAS NOT INFECTED AND HEALED ON ITS OWN AFTER REPEATED LOCAL IRRIGATION AND SITE INTERVENTION WITH ANTISEPTIC MOUTHWASH. POSTOPERATIVE WOUND INFECTION AND PINHOLE FISTULAS (N=2). TREATMENT: WHICH HEALED AFTER LOCAL IRRIGATION WITH SALINE AND ANTIBIOTIC TREATMENT IN CONCLUSION, CTAC IS A COMPREHENSIVE RESTORATIVE SOLUTION FOR ALVEOLAR CLEFT REPAIR THAT INTEGRATES MULTIPLE CONCEPTS, INCLUDING ORTHODONTICS, EMBRYOLOGY, ANATOMY, AND IMPROVEMENTS TO SURGICAL METHODS. THE METHOD IS EASY TO PERFORM, CAUSES LITTLE SURGICAL TRAUMA, AND SHOWS A STABLE SUCCESS RATE, AND IS THUS WORTH PROMOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078131 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention