BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8936329 · Received August 27, 2019

    Report

    Report Number
    2210968-2019-86321
    Event Type
    Injury
    Date Received
    August 27, 2019
    Report Date
    August 1, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: BRITISH JOURNAL OF SURGERY 2005; 92: 1085¿1091; DOI: 10.1002/BJS.5137. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: RANDOMIZED CLINICAL TRIAL COMPARING 5-YEAR RECURRENCE RATE AFTER LAPAROSCOPIC VERSUS SHOULDICE REPAIR OF PRIMARY INGUINAL HERNIA. THE AIM OF THIS STUDY WAS TO COMPARE THE 5-YEAR RECURRENCE RATES AFTER SHOULDICE AND LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL PATCH (TAPP) REPAIR FOR PRIMARY INGUINAL HERNIA. BETWEEN FEBRUARY 1993 AND MARCH 1996, 1183 PATIENTS WITH PRIMARY INGUINAL HERNIAS WERE RANDOMIZED INTO TWO GROUPS IN WHICH 920 PATIENTS COMPLETED THE 5 -YEAR FOLLOW UP: IN TAPP GROUP (N=454; MEAN AGE 51.2 YEARS) AND IN SHOULDICE GROUP (N=466; MEAN AGE=52.2). IN THE TAPP OPERATION, THE PERITONEUM WAS OPENED ABOVE THE INTERNAL RING AND THE PREPERITONEAL SPACE WAS ENTERED. AFTER DISSECTION OF THE HERNIA SAC AND PREPARATION OF COOPER¿S LIGAMENT AND THE TRIANGLE OF DOOM, A 7 X 12 CM PROLENE MESH (ETHICON) WAS INSERTED AND STAPLED IN PLACE USING AN ENDOSCOPIC STAPLER (EMS MULTIFEED STAPLEGUN, ETHICON). CARE WAS TAKEN NOT TO USE STAPLES BELOW THE ILIOPUBIC TRACT. THE PERITONEUM WAS STAPLED IN PLACE TO COVER THE MESH COMPLETELY. IN TAPP REPAIR, RECURRENCE (N=30) WAS OBSERVED OF WHICH, THE PATIENTS WERE EITHER REOPERATED OR HAD A POSITIVE HERNIOGRAM. IN THIS RANDOMIZED MULTICENTRE TRIAL THERE WAS NO DIFFERENCE IN THE 5-YEAR RECURRENCE RATE AFTER LAPAROSCOPIC TAPP AND SHOULDICE REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730026 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention