BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM

    MDR report key: 8471964 · Received April 1, 2019

    Report

    Report Number
    2210968-2019-79882
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    March 5, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A JOURNAL ARTICLE ENTITLED: POST-TRAUMATIC LUMBAR HERNIA REPAIRED WITH PHS. AUTHOR: MIN CHUNG. CITATION: J KOREAN SURG SOC 2009; 77: 221-224; DOI: 10.4174/JKSS.2009.77.3.221. THIS STUDY AIMED TO PRESENT A (B)(6)-YEAR-OLD MALE PATIENT WHO WAS DIAGNOSED WITH GRYNFELTT HERNIA IN THE UPPER LUMBAR TRIANGLE IN WHICH HE UNDERWENT SURGERY. IN THE SURGERY, A PROLENE HERNIA SYSTEM (PHS) OF MEDIUM SIZE WAS INSERTED INTO THE PREPERITONEAL SPACE USING RING FORCEPS. BOTH WING PARTS OF THE ONLAY MESH WERE CUT OUT HORIZONTALLY, AND AN INTERRUPT SUTURE WAS PERFORMED IN FOUR PLACES AROUND THE CONNECTOR WITH SUTURE PROLENE 3-0. ONE MONTH AFTER DISCHARGE, HE COMPLAINED OF BLOATING AT THE SURGICAL SITE WHICH WAS DIAGNOSED AS SEROMA. IN THE OUTPATIENT ROOM, 10 ML OF SEROMA FLUID WAS ASPIRATED WITH A SYRINGE. THE PHS USES THE PREPERITONEAL SPACE AS IN THE LAPAROSCOPIC PROCEDURE, AND THE CONNECTOR FIXES THE MESH IN PLACE, EVEN THOUGH THE SURROUNDING TISSUE OF THE LUMBAR HERNIA IS WEAK ENOUGH TO FIX, AND THE UNDERLAY COVERS THE HERNIATION WELL ENOUGH TO MAKE HERNIA REPAIR SAFE AND EASY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263402 PROLENE HERNIA SYSTEM MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention