BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 23704601 · Received December 3, 2025

    Report

    Report Number
    2210968-2025-13514
    Event Type
    Injury
    Date Received
    December 3, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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: LANGENBECKS ARCH SURG. 2025 AUG 29;410(1):258. HTTPS://DOI.ORG/10.1007/S00423-025-03845-Y PMID: 40879828; PMCID: PMC12397157.

    Description of Event or Problem · 0

    TITLE: PARTIAL RESECTION OF RECTUM FOR RECTAL GIST BY POSTERIOR APPROACH. THE AIM OF THIS STUDY IS TO PRESENT OUR SURGICAL PROCEDURE OF POSTERIOR APPROACH AND RETROSPECTIVELY ANALYZE THE EFFICACY AND SAFETY OF THIS APPROACH. BETWEEN JANUARY 2018 TO DECEMBER 2023 AT FUKUSHIMA MEDICAL UNIVERSITY HOSPITAL. A TOTAL OF FOUR MALE PATIENTS WITH RECTAL GIST WERE INCLUDED. THE MEDIAN AGE WAS 50.5 YEARS, AND ALL PATIENTS WERE MALE. THE DEFECT IN THE RECTAL WALL WAS CLOSED WITH 4-0 PDS SUTURES (JOHNSON & JOHNSON, NEW JERSEY, U.S.). A BLAKE SILICONE DRAIN (JOHNSON & JOHNSON, NEW JERSEY, U.S.). AND THE ILIOCOCCYGEUS MUSCLE WAS SUTURED WITH 4-0 PDS, AND THE GLUTEUS MAXIMUS MUSCLE WAS SUTURED WITH 0 VICRYL (JOHNSON & JOHNSON, NEW JERSEY, U.S.). REPORTED COMPLICATIONS ARE: 4-0 PDS SUTURES (ETHICON) 71 YEARS OLD, MALE: OUTLET OBSTRUCTION OF THE DIVERTING ILEOSTOMY AND MAJOR LARS (THE LARS SCORE WAS 39 POINTS TWO YEARS AFTER THE CLOSURE OF THE DIVERTING ILEOSTOMY) (N=1). TREATMENT: NOT PROVIDED. BLAKE SILICONE DRAIN (ETHICON). 71 YEARS OLD, MALE: OUTLET OBSTRUCTION OF THE DIVERTING ILEOSTOMY AND MAJOR LARS (THE LARS SCORE WAS 39 POINTS TWO YEARS AFTER THE CLOSURE OF THE DIVERTING ILEOSTOMY) (N=1). TREATMENT: NOT PROVIDED. 0 VICRYL (ETHICON). 71 YEARS OLD, MALE: -OUTLET OBSTRUCTION OF THE DIVERTING ILEOSTOMY AND MAJOR LARS (THE LARS SCORE WAS 39 POINTS TWO YEARS AFTER THE CLOSURE OF THE DIVERTING ILEOSTOMY) (N=1). TREATMENT: NOT PROVIDED. IN CONCLUSION, THIS STUDY DEMONSTRATED THAT POSTERIOR APPROACH IS SAFE, ASSOCIATED WITH A LOW INCIDENCE OF LOW ANTERIOR RESECTION SYNDROME (LARS), AND FACILITATES COMPLETE RESECTION, MAKING IT A VALUABLE SURGICAL OPTION FOR RECTAL GASTROINTESTINAL STROMAL TUMORS (GISTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2863516 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other