BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 8846401 · Received July 31, 2019

    Report

    Report Number
    2210968-2019-84928
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    July 4, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: HERNIA (2009); 13:23¿27. DOI 10.1007/S10029-008-0418-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: MULTICENTRIC OBSERVATIONAL COHORT STUDY EVALUATING A COMPOSITE MESH WITH INCORPORATED OXIDIZED REGENERATED CELLULOSE IN LAPAROSCOPIC VENTRAL HERNIA REPAIR. THIS STUDY EXAMINED A MULTICENTRIC EXPERIENCE WITH THE PROCEED MESH FOR LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH PERIOPERATIVE EVALUATION AT SHORT- AND MID-TERM FOLLOW-UP BY EXPERIENCED LAPAROSCOPIC SURGEONS AT SIX DIFFERENT HOSPITALS. BETWEEN OCTOBER 2004 AND DECEMBER 2006, 114 PATIENTS (61 MALE AND 53 FEMALE; AGE RANGE: 19-84 YEARS) UNDERWENT A LAPAROSCOPIC VENTRAL HERNIA REPAIR. BEGINNING OCTOBER 2004, PROCEED MESH (ETHICON) WAS USED FOR LAPAROSCOPIC VENTRAL HERNIA REPAIR. REPORTED COMPLICATIONS INCLUDED SEROMAS/HEMATOMAS (N-12) IN WHICH 4 PATIENT NEEDED THERAPY, CHRONIC PAIN (>6 MONTHS) AT THE LEVEL OF FIXATION TACKS (N-1) IN WHICH INFILTRATIONS WITH LONG-ACTING ANESTHETICS WAS GIVEN, CHRONIC PAIN (>6 MONTHS) DUE TO ADHESIONS (N-1) IN WHICH A RELAPAROSCOPY WAS PERFORMED WITH RESOLUTION OF THE COMPLAINTS, RECURRENCES (N-4) IN WHICH 3 PATIENTS WERE REOPERATED, AND ADHESION TO BOTH THE MESH AND THE TACKERS (N-3) WHICH WERE TREATED BY A SECOND LAPAROSCOPIC PROCEDURE USING AN EXTRA SHEET OF PROCEED MESH WITHOUT FURTHER COMPLICATIONS. IN CONCLUSION, THE MULTICENTRIC STUDY DOCUMENTS A FAVORABLE EXPERIENCE USING LARGE-PORE MESH IN LAPAROSCOPIC VENTRAL HERNIA REPAIR. TECHNICAL ADVANTAGES CONSIDERING MESH HANDLING AND LONG-TERM ADVANTAGES CONSIDERING CHRONIC PAIN MIGHT BE OF INTEREST WITH THE USE OF THIS LIGHTWEIGHT MESH FOR MINIMALLY INVASIVE VENTRAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641048 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention