BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT

    MDR report key: 8445000 · Received March 22, 2019

    Report

    Report Number
    2210968-2019-79614
    Event Type
    Injury
    Date Received
    March 22, 2019
    Report Date
    February 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: AMBULATORY INGUINAL HERNIA REPAIR WITH PROLENE HERNIA SYSTEM (PHS)" AUTHORS: M. FARRAKHA, V. SHYAM, G. A. BEBARS, M. YACOUB, K. BINDU, S. KOLLI CITATION: HERNIA. 2006; 10: 2¿6. DOI: 10.1007/S10029-005-0007-9. THE STUDY WAS CONDUCTED TO EVALUATE THE FEASIBILITY AND BENEFITS OF INGUINAL HERNIA REPAIR WITH PROLENE HERNIA SYSTEM (PHS) MESH (ETHICON) UNDER LOCAL ANESTHESIA AS A DAY SURGERY PROCEDURE IN A MULTINATIONAL SOCIETY OF UNITED ARAB EMIRATES. A TOTAL OF 154 PATIENTS (AGE RANGE: 18 TO 74 YEARS OLD) FITTED THE CRITERIA AND WERE INCLUDED IN THE STUDY. THE HERNIA REPAIR WAS PERFORMED BY THE PLACEMENT OF PHS MESH. A PREPERITONEAL SPACE WAS THEN CREATED BEHIND THE TRANSVERSALIS FASCIA FOR THE PLACEMENT OF THE DEEP LAYER OF THE PHS MESH. THE CONNECTING CYLINDER OF THE PHS MESH WAS FIXED TO THE INTERNAL RING BY ONE OR TWO PROLENE SUTURES (ETHICON), AND THE SUPERFICIAL LAYER OF THE PHS MESH WAS SPREAD ONTO THE FLOOR OF THE INGUINAL CANAL USING FEW PROLENE 2-0 SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED SCROTAL EDEMA (N-6), MILD WOUND ERYTHEMA (N-9), WOUND INFECTION (N-1), AND HERNIA RECURRENCE (N-1) WHICH WAS RE-OPERATED USING THE SAME TECHNIQUE. THE PRESENT STUDY HAS DEMONSTRATED THAT INGUINAL HERNIA REPAIR WITH PHS PERFORMED UNDER LOCAL ANESTHESIA, ON A DAY-CASE BASIS, IS SAFE AND FEASIBLE PROCEDURE. IT IS ASSOCIATED WITH MINIMAL POSTOPERATIVE MORBIDITY, ACCEPTABLE LEVELS OF POSTOPERATIVE PAIN, EARLY MOBILIZATION, AND REDUCED COSTS OF HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236378 PROLENE HERNIA SYSTEM MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention