BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 22073950 · Received May 22, 2025

    Report

    Report Number
    2210968-2025-05785
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    May 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. CITATION: MESSER N, BERTKE A, MILLER BT, BEFFA LRA, PETRO CC, KRPATA DM, LAHAT G, NIZRI E, ABU-ABEID A, KANANI F, LESSING Y, MCMICHAEL J, ROSEN MJ, PRABHU AS. OUTCOMES OF ABDOMINAL WALL CLOSURE WITH FASCIAL BRIDGING USING A POLYGLACTIN 910 (VICRYL) MESH FOLLOWING NON-TRAUMA LAPAROTOMY: A MULTI-CENTER STUDY. HERNIA. 2025 MAY 2;29(1):153. DOI: 10.1007/S10029-025-03346-3. PMID: 40314824.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: MESSER N, BERTKE A, MILLER BT, BEFFA LRA, PETRO CC, KRPATA DM, LAHAT G, NIZRI E, ABU-ABEID A, KANANI F, LESSING Y, MCMICHAEL J, ROSEN MJ, PRABHU AS. OUTCOMES OF ABDOMINAL WALL CLOSURE WITH FASCIAL BRIDGING USING A POLYGLACTIN 910 (VICRYL) MESH FOLLOWING NON-TRAUMA LAPAROTOMY: A MULTI-CENTER STUDY. HERNIA. 2025 MAY 2;29(1):153. DOI: 10.1007/S10029-025-03346-3. PMID: 40314824. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE OUTCOMES OF FASCIAL BRIDGING UTILIZING VICRYL MESH FOR NON-TRAUMA LAPAROTOMIES. BETWEEN JANUARY 2018 AND APRIL 2023, A TOTAL OF 202 PATIENTS WHO UNDERWENT ABDOMINAL WALL CLOSURE USING VICRYL MESH AT CLEVELAND CLINIC CENTER WERE INCLUDED IN THE STUDY. THE MEDIAN FOLLOW-UP OF 47 MONTHS (SD±18.9 MONTHS). REPORTED COMPLICATIONS INCLUDE SURGICAL SITE INFECTIONS (N=48.5%), SKIN DEHISCENCE (N=27.2%), SOFT TISSUE NECROSIS (N=9.9%), BOWEL EVISCERATION SECONDARY TO MESH DETACHMENT (N=2%), AND ENTEROCUTANEOUS FISTULAS (N=8.4%). IN CONCLUSION, FASCIAL BRIDGING WITH VICRYL MESH IS A SAFE METHOD FOR ABDOMINAL WALL CLOSURE, WITH ENTEROCUTANEOUS FISTULA AND SMALL BOWEL OBSTRUCTION RATES COMPARABLE TO THOSE SEEN WITH OTHER TECHNIQUES. NEVERTHELESS, PRIMARY CLOSURE OF THE LINEA ALBA SHOULD BE PRIORITIZED, WITH MESH IMPLANTATION MINIMIZED WHENEVER FEASIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514796 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other