BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 8859479 · Received August 5, 2019

    Report

    Report Number
    2210968-2019-85137
    Event Type
    Injury
    Date Received
    August 5, 2019
    Report Date
    July 8, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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: SAUDI MED J 2011; VOL. 32 (5): 504-509. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: REPAIR OF LARGE ABDOMINAL WALL DEFECTS USING THE PROCEED¿SURGICAL MESH WITH OPEN INTRA-PERITONIUM ONLAY METHOD. IN THIS STUDY, THE AUTHORS REPORTED THEIR EXPERIENCE WITH THE USE OF PROCEED MESH IN THE MANAGEMENT OF LARGE ABDOMINAL WALL DEFECTS WITH INTRA-PERITONIUM ONLAY METHOD. BETWEEN MAY 2007 AND JUNE 2010, 36 CONSECUTIVE PATIENTS (20 MALE AND 16 FEMALE; AGE RANGE: 19-76 YEARS; WEIGHT: 54-109 KG) WITH LARGE ABDOMINAL WALL DEFECTS WERE INCLUDED IN THIS STUDY. OVERALL 36 ABDOMINAL WALL DEFECTS WERE REPAIRED USING PROCEED MESH (ETHICON). REPORTED COMPLICATIONS INCLUDED SEROMAS (N-6) WHICH WERE MANAGED BY PERCUTANEOUS ASPIRATION AND PRESSURE DRESSING, LOCALIZED WOUND INFECTION (N-1) WHICH WAS MANAGED CONSERVATIVELY WITH ANTIBIOTICS AND PHYSICAL THERAPY WITHOUT REMOVING THE MESH, AND WOUND SINUS (N-1) WHICH WAS MANAGED BY WOUND DRESSING AND ALBUMIN GEL PERFUSION. IN CONCLUSION, THE INTRA-PERITONEUM REPAIR TECHNIQUE FOR A LARGE ABDOMINAL WALL DEFECT USING PROCEED MESH IS A FEASIBLE AND SAFE METHOD, WITH NO MAJOR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653444 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention