BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8478373 · Received April 3, 2019

    Report

    Report Number
    2210968-2019-79950
    Event Type
    Injury
    Date Received
    April 3, 2019
    Report Date
    March 6, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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: SURGICAL REVIEW 2005, 77, 1, 20-29. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PROLENE HERNIA SYSTEM (PHS) IN THE TREATMENT OF INGUINAL HERNIAS. THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO EVALUATE THE RESULTS OBTAINED FOLLOWING INGUINAL HERNIA TREATMENT BY MEANS OF THE PROLENE HERNIA SYSTEM (PHS) METHOD. BETWEEN NOV1999 AND DEC2002, A TOTAL OF 144 PATIENTS [N=138 MALE, N=6 FEMALE, MEAN AGE 65 YEARS (18 TO 95YEARS)] WITH INGUINAL HERNIAS WERE INCLUDED IN THE STUDY. INTRAOPERATIVELY, DECISION CONCERNING THE SIZE OF THE MESH WAS UNDERTAKEN: MEDIUM (PHSM), EXTENDED (PHSE) OR LARGE (PHSSL). AFTER EXPLORING THE CONTENTS OF THE HERNIA SAC IT WAS REDUCED INTO THE ABDOMINAL CAVITY OR CUT OFF, THEN LIGATED WITH ABSORBABLE SUTURES AND FIXED. AFTER ISOLATING THE SPACE IN THE PREPERITONEAL AREA, AN UNDERLYING PATHC OF PHS MESH WAS PLACED, AND THE CONNECTOR WAS INSERTED THROUGH THE DEEP INGUINAL RING FOR OBLIQUE HERNIAS OR THROUGH THE DEFECT IN THE POSTERIOR WALL OF THE INGUINAL CANAL FOR DIRECT HERNIAS. THE ONLAY PATCH WAS PLACED ON THE POSTERIOR WALL OF THE INGUINAL CANAL, AND A SMALL INCISION WAS MADE TO INSERT EITHER THE SPERMATIC CORD OR ROUND LIGAMENT OF THE UTERUS. THE ONLAY PATCH WAS SUTURED TO THE PUBIC TUBERCULUM BY MEANS OF SINGLE NON-ABSORBABLE SUTURES. POSTOPERATIVE COMPLICATIONS INCLUDED HERNIA RECURRENCE (N=1) WHICH WAS REOPERATED ONE MONTH AFTER, IN WHICH THE PHS MESH REMAINED IN PLACE, AND HERNIA RING WAS REPAIRED BY MEANS OF POLYPROPYLENE PLUGS; WOUND SUPPURATION (N=3) WITHOUT THE NEED TO REMOVE THE MESH; SEROMA (N=1); SCROTAL EDEMA PERSISTING FOR 1 MONTH (N=2); INGUINAL NEURALGIA/DYSESTHESIA (N=2); CHRONIC GROIN PAIN (N=6) CONTINUOUS INGUINAL PAIN UNTIL 3MONTHS AFTER THE PROCEDURE, ANALGESIA WAS NOT REQUIRED; AND HEMATOMA (N=2). THE PROLENE HERNIA SYSTEM (PHS) IS AN EFFECTIVE METHOD OF INGUINAL HERNIA REPAIR WITH A LOW RATE OF POSTOPERATIVE COMPLICATIONS AND RECURRENCES. REDON DRAINAGE IN SELECTED CASES OF INGUINAL HERNIA REPAIR DECREASES THE RATE OF LOCAL COMPLICATIONS, SUCH AS HEMATOMAS AND SEROMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272333 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention