BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8423462 · Received March 15, 2019

    Report

    Report Number
    2210968-2019-79495
    Event Type
    Injury
    Date Received
    March 15, 2019
    Report Date
    February 28, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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: REV. COL. BRAS. CIR. 2011; 38(1): 024-027 / HTTP://WWW.SCIELO.BR/RCBC. [(B)(4)].

    Description of Event or Problem · 1

    TITLE: USING THE PROLENE HERNIA SYSTEM (PHS) FOR INGUINAL HERNIA REPAIR. THE PURPOSE OF THIS RETROSPECTIVE AND DESCRIPTIVE STUDY IS TO ASSESS IMMEDIATE POSTOPERATIVE AND LATE COMPLICATIONS IN PATIENTS WITH INGUINAL HERNIA UNDERGOING SURGICAL CORRECTION BY GILBERT TECHNIQUE, USING THE PROLENE HERNIA SYSTEM (PHS). FROM JAN 2001 TO OCT 2006, A TOTAL OF 96 PATIENTS [N=86 MEN, N=10 WOMEN, MEAN AGE 56.9 YEARS (18-86 YEARS)] WITH INGUINAL HERNIA (DIRECT, INDIRECT OR MIXED) WERE INCLUDED IN THE STUDY. THE PHS WAS USED IN ALL STUDY PATIENTS, ACCORDING TO THE TECHNIQUE DESCRIBED BY GILBERT. POSTOPERATIVE COMPLICATIONS INCLUDED SEROMA GRADES 1 AND 2 (N=2), HEMATOMA GRADE 2 (N=1), WOUND INFECTION GRADE 1 (N=1) TREATED WITH ANTIBIOTICS, SCROTAL EDEMA (N=2), CHRONIC PAIN CHARACTERIZED AS PAIN OR DISCOMFORT THAT MAY AFFECT DAILY ACTIVITIES (N=2), HERNIA RECURRENCE 26 MONTHS AFTER SURGERY (N=1), AND DISCOMFORT AS AN OCCASIONAL PAIN WITH NO CHANGE IN DAILY ACTIVITIES (N=7). ALL COMPLICATIONS WERE TREATED MEDICALLY OR WITH WOUND EXPLORATION (SEROMA AND INFECTION), WITHOUT NEED FOR SURGICAL RE-EXPLORATION FOR REMOVAL OR REPOSITIONING OF THE MESH. SURGICAL TREATMENT OF INGUINAL HERNIA USING THREE DIMENSIONAL MESH IS SAFE, EFFECTIVE, REPRODUCIBLE AND DISPLAYS LOW COMPLICATIONS, RECURRENCE OR SYMPTOMS INCIDENCES IN THE LONG TERM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219352 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention