BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 16528656 · Received March 13, 2023

    Report

    Report Number
    2210968-2023-01646
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    May 16, 2002
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. ADVERSE EVENT PROBLEM COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.CITATION: HTTPS://DOI.ORG/10.1007/S10029-022-02622-W.

    Description of Event or Problem · 0

    TITLE: THE COMBINATION OF THE THREE MODIFICATIONS OF THE COMPONENT SEPARATION TECHNIQUE IN THE MANAGEMENT OF COMPLEX SUBCOSTAL ABDOMINAL WALL HERNIA. THE PURPOSE OF THIS STUDY IS TO PRESENT A CONCEPT COMBINING THREE MODIFICATIONS OF THE COMPONENT SEPARATION TECHNIQUE (CST) IN ONE PROCEDURE AS AN ORIGINAL SOLUTION FOR THE MANAGEMENT OF COMPLEX SUBCOSTAL ABDOMINAL WALL HERNIA. BETWEEN JANUARY 2010 AND JANUARY 2020, SEVEN PATIENTS PRESENTING AT THE HIGH-VOLUME ACADEMIC CENTER WITH COMPLEX SUBCOSTAL HERNIA UNDERWENT SURGERY IN WHICH THREE MODIFICATIONS OF CST WERE COMBINED INTO ONE PROCEDURE. MAJOR COMPLEX SUBCOSTAL HERNIA WAS DEFINED BY EITHER WIDTH OR LENGTH OF THE DEFECT BEING GREATER THAN 10 CM. THE FOLLOWING WERE THE STAGES OF THE OPERATIVE TECHNIQUE: (A) THE ¿METHOD OF WIDE MYOFASCIAL RELEASE¿ AT THE SIDE OF THE HERNIA DEFECT; (B) ¿OPENBOOK VARIATION¿ OF THE COMPONENT SEPARATION TECHNIQUE AT THE OPPOSITE SIDE OF THE HERNIA DEFECT; (C) A MODIFIED COMPONENT SEPARATION TECHNIQUE FOR CLOSURE OF MIDLINE ABDOMINAL WALL HERNIAS IN THE PRESENCE OF ENTEROSTOMIES; (D) SUTURING OF THE MYOFASCIAL FLAPS TO EACH OTHER TO COVER THE DEFECT; AND (E) REPAIR AUGMENTATION WITH AN ABSORBABLE MESH IN THE ONLAY POSITION. VYCRIL MESH (ETHICON, INC, SOMERVILLE, NJ) WAS USED. REPORTED COMPLICATIONS INCLUDED SEROMA (N=2), WOUND INFECTION (N=3), SKIN NECROSIS (N=1). IN CONCLUSION OPERATIVE TECHNIQUE INTEGRATING THREE MODIFICATIONS OF CST IN ONE PROCEDURE WITH ONLAY ABSORBABLE MESH REINFORCEMENT IS A FEASIBLE SOLUTION FOR THE MANAGEMENT OF COMPLEX SUBCOSTAL ABDOMINAL WALL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444924 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other