BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8039359 · Received November 5, 2018

    Report

    Report Number
    2210968-2018-76944
    Event Type
    Injury
    Date Received
    November 5, 2018
    Report Date
    October 18, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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 (2015) (SUPPI2): S3-S194. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE, TITLE: COMPONENTS SEPARATION TECHNIQUE IN THE MANAGEMENT OF LARGE VENTRAL HERNIAS: THE AIM OF THIS CURRENT STUDY WAS TO ASSESS THE FEASIBILITY AND EFFECTIVENESS OF COMPONENTS SEPARATION TECHNIQUE IN THE MANAGEMENT OF LARGE VENTRAL HERNIAS WITH PROLENE MESH REINFORCEMENT. PATIENTS WITH LARGE VENTRAL HERNIAS WITH DEFECT MORE THAN OR EQUAL TO 10 CMS UNDERWENT ELECTIVE REPAIR. IF PRIMARY FASCIAL CLOSURE WITHOUT TENSION WAS FEASIBLE, CLOSURE USING NON ABSORBABLE SUTURES WITH ON LAY MESH WAS DONE. IF NOT THEN COMPONENTS SEPARATION TECHNIQUE WITH ON LAY MESH REINFORCEMENT WAS PERFORMED. PREOPERATIVE PROGRESSIVE PNEUMOPERITONEUM WAS USED IN HERNIA WITH LOSS OF DOMAIN. THE PRESENT STUDY INCLUDED 20 PATIENTS WITH AGE RANGING FROM 34-65 YEARS & MEAN OF 48.05 ±8.2 YEARS. SIXTY (60%) OF THE PATIENTS HAD INCISIONAL HERNIAS, WHEREAS 25% HAD PRIMARY PUH AND THE REMAINING 15% HAD RECURRENT PUH. IN THE STUDY WE HAD ONE MORTALITY. AMONG POSTOPERATIVE COMPLICATIONS SEROMA OCCURRED IN (20%), WOUND INFECTION (15%), SKIN NECROSIS (10%), HEMATOMA (5%) ALL OF WHICH WERE TREATED CONSERVATIVELY. FOLLOW UP WAS UP TO 24 MONTHS. RECURRENCE WAS REPORTED IN ONE PATIENT AFTER ONE YEAR OF HERNIA REPAIR. IN CONCLUSION, COMPONENTS SEPARATION TECHNIQUE WITH PROSTHETIC REINFORCEMENT WAS FEASIBLE & VALUABLE IN PATIENTS WITH LARGE VENTRAL HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879147 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention