BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8402147 · Received March 7, 2019

    Report

    Report Number
    2210968-2019-79356
    Event Type
    Injury
    Date Received
    March 7, 2019
    Report Date
    February 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. 2004; 8: 203¿207. DOI: 10.1007/S10029-004-0238-1. (B)(4).

    Description of Event or Problem · 1

    TITLE: COMBINED ANTERIOR AND POSTERIOR INGUINAL HERNIA REPAIR: INTERMEDIATE RECURRENCE RATES WITH THREE GROUPS OF SURGEONS. THE USE OF A BILAYER POLYPROPYLENE MESH DEVICE (BPMD) OR THE PROLENE HERNIA SYSTEM (ETHICON) FOR INGUINAL HERNIA REPAIR BEGAN IN 1998. SURGEONS WHOSE PRACTICE IS DEDICATED TO HERNIA REPAIR TRAINED PRECEPTORS WHO, IN TURN, ASSISTED IN THE TRAINING OF OTHER SURGEONS IN THIS NEW TECHNIQUE. TO COMPARE THE RESULTS OBTAINED BY THREE GROUPS OF SURGEONS UTILIZING THIS BILAYER DEVICE, THE AUTHOR ESTABLISHED FOLLOW-UP STUDIES OF THREE SEPARATE GROUPS. THESE INCLUDED THE HERNIA INSTITUTE OF FLORIDA (HIF), A MULTICENTER ¿¿EXPERT¿¿ GROUP, AND A SEMINAR- OR PRECEPTOR-TRAINED ¿¿NONEXPERT¿¿ GROUP. IN THE HIF GROUP, A TOTAL OF 4273 PATIENTS (3965 MALE AND 308 FEMALE PATIENTS) UNDERWENT THE PROCEDURE AND WERE INCLUDED IN THE STUDY. IN THE HIF GROUP, REPORTED COMPLICATIONS INCLUDED RECURRENCE (N-3) WHICH REQUIRED RE-OPERATION IN 2 CASES, FAILED REPAIRS (N-2), WOUND INFECTION (N-22), SEROMA (N-77), HEMATOMA (N-21), AND TESTICULAR ATROPHY (N-1). TRAINING IN THE USE OF THE BPMD HAS BEEN EFFECTIVE, AS EVIDENCED BY THE RESULTS GAINED BY SURGEONS WHO WERE TUTORED. IN MOST CASES, SURGEONS WHO HAVE DONE FOUR BPMD REPAIRS ARE COMFORTABLE ENOUGH TO USE IT ROUTINELY AND PROBABLY ARE CAPABLE OF TEACHING COLLEAGUES THE TECHNIQUE OF DISSECTION AND INSTALLATION OF THE DEVICE. THE USE OF THE BPMD (PROLENE HERNIA SYSTEM) PROVIDES RELIABLE RESULTS IN THE HANDS OF HERNIA SPECIALISTS, AS WELL AS GENERAL SURGEONS WHOSE PRACTICES ARE NOT CONCENTRATED ON THE MANAGEMENT OF HERNIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192440 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention