BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 23993994 · Received January 7, 2026

    Report

    Report Number
    2210968-2026-00134
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    January 1, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    TITLE: OC-034 SHORT- AND LONG-TERM OUTCOMES OF TEMPORISING ABDOMINAL CLOSURE WITH VICRYL MESH IN CONTAMINATED AND INFECTED FIELDS. AUTHORS: E. SCHEMBARI, M. WOYTON, L. HENDRA, C. RICHARDSON, A. KING, D. LAYFIELD ABSTRACT CITATION ID: ZNAD080.041. THE AIM OF THIS STUDY IS TO REPORTS OUTCOMES FOLLOWING TEMPORISING ABDOMINAL CLOSURE IN CONTAMINATED FIELDS. BETWEEN 2010¿2019, A TOTAL OF 26 PATIENTS UNDERGOING INTESTINAL FAILURE SURGERY IN WHOM TEMPORISING ABDOMINAL CLOSURE USING 4-LAYERS OF VICRYL MESH PLACED AS AN INLAY, SECURED CIRCUMFERENTIALLY USING CONTINUOUS ABSORBABLE SUTURE. REPORTED COMPLICATIONS ARE: N=13; NOTABLE PERSISTENT ABDOMINAL WALL HERNIATION. TREATMENT: NOT REPORTED. IN CONCLUSION, TEMPORISING VICRYL MESH CLOSURE IS A SIMPLE METHOD ASSOCIATED WITH LOW SURGICAL SITE MORBIDITY IN CONTAMINATED FIELDS. DESPITE PERSISTENT HERNIATION RE-FISTULATION RATES ARE LOW AND THE MAJORITY OF PATIENTS ARE FREE OF ABDOMINAL WALL MORBIDITY AT FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50549 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other