BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8448566 · Received March 25, 2019

    Report

    Report Number
    2210968-2019-79511
    Event Type
    Injury
    Date Received
    March 25, 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
    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: CITATION: SURGERY TODAY. 2006; 36: 1058-1062. DOI: 10.1007/S00595-006-3311-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: "LONG-TERM OUTCOME AFTER HERNIA REPAIR WITH THE PROLENE HERNIA SYSTEM." THE PURPOSE OF THIS STUDY IS TO EVALUATE THE LONG-TERM OUTCOME AND SYMPTOMS AFTER INGUINAL HERNIA REPAIR USING THE PROLENE HERNIA SYSTEM (PHS; ETHICON). FROM DECEMBER 1998 AND DECEMBER 2004, A TOTAL OF 395 HERNIAS IN 367 PATIENTS (328 MALE AND 39 FEMALE PATIENTS; AGE RANGE: 14 TO 91 YEARS OLD) WHO UNDERWENT PHS HERNIA REPAIR WERE STUDIED. THE PHS USES TWO MECHANISMS TO REINFORCE THE POSTERIOR WALL OF THE INGUINAL CANAL. THE UNDERLAY IS PLACED UNDER THE TRANSVERSALIS FASCIA TO SUPPORT THE FLOOR OF THE INGUINAL CANAL FROM THE POSTERIOR SIDE, AS IN THE LAPAROSCOPIC REPAIR, AND THE OVERLAY IS PLACED TO SUPPORT THE ANTERIOR SIDE, AS IN LICHTENSTEIN¿S REPAIR. THUS, THE PHS HAS AN IDEAL STRUCTURE TO MAINTAIN THE INTEGRITY OF THE ABDOMINAL WALL WITHOUT ANY TENSION. REPORTED POST-OPERATIVE COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTION (N-9), MESH INFECTION (N-1), HEMATOMA (N-6), SEROMA (N-6), AND SCROTAL SWELLING (N-1). REPORTED LATE POSTOPERATIVE SYMPTOMS INCLUDED PAIN (N-59) AND DISCOMFORT (N-55). IT WAS CONCLUDED THAT THE PROLENE HERNIA SYSTEM IS A SAFE AND FEASIBLE PROCEDURE WITH LOW RATES OF COMPLICATION, RECURRENCE, AND LATE SYMPTOMS. THE STUDY MAY HELP TO EVALUATE THE BENEFITS OF PHS SURGERY IN A PHASE III TRIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243210 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention