BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22241176 · Received June 17, 2025

    Report

    Report Number
    2210968-2025-07006
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    January 13, 2025
    Report Date
    June 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    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: CURR PROBL SURG. 2025 MAR;64:101721. HTTPS://DOI.ORG/10.1016/J.CPSURG.2025.101721. EPUB 2025 JAN 13. PMID: 40057329.

    Description of Event or Problem · 0

    TITLE: PREOPERATIVE MRI-BASED SURGICAL DECISION SUPPORT FOR THE BARED EXTERNAL SPHINCTER IN HORSESHOE ANAL FISTULA: A CROSS-CENTER RETROSPECTIVE STUDY. THE PRIMARY AIM OF THIS STUDY WAS TO INTEGRATE MRI WITH KEY PREOPERATIVE CLINICAL PARAMETERS BASED ON POSTOPERATIVE RECURRENCE STATISTICS, ADDRESSING THE CURRENT GAP IN SURGICAL DECISION-MAKING FOR BARED EXTERNAL ANAL SPHINCTER (BEAS) AND ENHANCING THE ACCURACY OF PREOPERATIVE ASSESSMENTS. THIS STUDY INVOLVED A RETROSPECTIVE ANALYSIS OF PATIENT DATA FROM 2 CENTERS: BAOSHAN HOSPITAL OF INTEGRATED TRADITIONAL CHINESE AND WESTERN MEDICINE (CENTER 1) AND SHUGUANG HOSPITAL AFFILIATED TO SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE (CENTER 2) BETWEEN JANUARY 2018 AND MARCH 2023. 252 CASES (215 MALE AND 37 FEMALE) FROM CENTER 1 AND 107 (96 MALE AND 11 FEMALE) FROM CENTER 2 WERE INCLUDED IN THE STUDY. AFTER IRRIGATING THE DPIS AND DPAS WITH HYDROGEN PEROXIDE AND POVIDONE IODINE, A 2-0 POLYGLACTIN SUTURE (COATED VICRYL, 2-0, ETHICON INC, CHINA) IS USED TO INSERT SUTURES AT THE LES APPROACH ON BOTH SIDES, APPROXIMATELY 0.5 CM ABOVE THE IO, WHERE IT MEETS THE EAS. THE NEEDLE ENTRY ROUTE IS SHOWN IN FIG. 3B. ONCE THE NEEDLE ENTRY POINTS ARE IDENTIFIED, AN INTERRUPTED SUTURE TECHNIQUE IS APPLIED TO CLOSE THE INTERSPHINCTERIC APPROACH, COMPLETING THE ADVANCEMENT OF THE IAS MUSCULOMUCOSAL FLAP AND EAS. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE RECURRENCE (N=96). IN CONCLUSION, THE NEWLY DEVELOPED BEAS DECISION-MAKING TOOL, WHICH INTEGRATES PREOPERATIVE MRI FEATURES, SHOWS SIGNIFICANT POTENTIAL IN GUIDING SURGICAL DECISIONS FOR HAF. THIS MODEL SERVES AS A PROMISING NONINVASIVE TOOL, ENABLING TAILORED TREATMENT STRATEGIES AND AIDING CLINICIANS IN MAKING MORE INFORMED DECISIONS. ITS EFFECTIVENESS IN PROGNOSIS REPRESENTS AN IMPORTANCE ADVANCEMENT IN PATIENT-SPECIFIC SURGICAL MANAGEMENT OF HAF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450087 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other