BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8481195 · Received April 3, 2019

    Report

    Report Number
    2210968-2019-80007
    Event Type
    Injury
    Date Received
    April 3, 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
    JA
    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: JOURNAL OF JAPANESE COLLEGE OF SURGEONS 33 (6): 916-919, 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: "A CASE REPORT OF ABDOMINAL HERNIA REPAIR WITH THE PROLENE HERNIA SYSTEM AND SEPRAFILM." THIS STUDY AIMED TO PRESENT AN (B)(6) FEMALE PATIENT WHO DEVELOPED ABDOMINAL INCISIONAL HERNIA AFTER THE OPERATION FOR CHOLEDOCHOLITHIASIS. THIS PATIENT UNDERWENT HERNIOPLASTY USING PROLENE HERNIA SYSTEM (PHS) AND SEPRAFILM ADHESION BARRIER. IN THE PROCEDURE, RECTUS ABDOMINIS MUSCLE WAS SHAPED TO BE PINCHED BETWEEN AN ONLAY PATCH AND UNDERLAY PATCH PHS M WAS DECIDED ON. SEPRAFILM WAS FIRST SPREAD IN THE ABDOMINAL CAVITY AND THEN THE UNDERLAY PATCH WAS INSERTED ON TOP OF IT. THE ONLAY PATCH WAS THEN LIGATED AND WAS COMPLETELY SUTURED CIRCUMFERENTIALLY AT 5 MM INTERVALS USING ANTERIOR SHEATH OF RECTUS ABDOMINIS MUSCLE AND A 3-0 VICRYL THREAD. AT FOURTH POSTOPERATIVE DAY, REDNESS OF THE WOUND APPEARED AND THE BULGING OF THE WOUND BECAME CONSPICUOUS AT 8TH POSTOPERATIVE DAY. ABDOMINAL CT SCAN REVEALED EFFUSION AIR UNDER SKIN. REOPERATION WAS PERFORMED IN WHICH FLUID WAS ACCUMULATED. WITHOUT TOUCHING THE PHS, A CONTINUOUS CLOSED SUCTION DRAINAGE (SB BAG) WAS PLACED IN ORDER TO PREVENT SUBCUTANEOUS EDEMA, AND THEN THE SKIN WAS SUTURED CLOSED. THERE WAS NO RECURRENCE OR INFECTION IN THE FOLLOW-UP CHECKUP AFTER FIVE YEARS OF THE OPERATION. THE EFFUSION THAT HAD ACCUMULATED WAS CAUSED BY THE TURNOVER OF ONLAY PATCH, CREATING A SPACE UNDER THE SKIN WITH RECESS ON THE CONNECTOR, SINCE THE SEPARATION BETWEEN THE SUBCUTANEOUS TISSUE AND THE ANTERIOR SHEATH OF RECTUS ABDOMINIS MUSCLE WAS INSUFFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270885 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention