BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    MDR report key: 8448752 · Received March 25, 2019

    Report

    Report Number
    2210968-2019-79634
    Event Type
    Injury
    Date Received
    March 25, 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 · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO FDA: 5/27/2019. PATIENT CODES: 3189 - TESTICULAR ATROPHY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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: HERNIA. 2010; 14: 155¿158. DOI: 10.1007/S10029-009-0576-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: "FIVE-YEAR RESULTS OF INGUINAL HERNIA TREATMENT WITH THE PROLENE HERNIA SYSTEM IN A REGIONAL TRAINING HOSPITAL." LONG-TERM RESULTS OF INGUINAL HERNIA REPAIR WITH THE PROLENE HERNIA SYSTEM (PHS; ETHICON) IN OUR REGIONAL TRAINING HOSPITAL WERE RETROSPECTIVELY ANALYSED. RESEARCH WAS CONDUCTED IN AN IDENTICAL COHORT OF PATIENTS PREVIOUSLY INVESTIGATED FOR SHORT-TERM RESULTS. A TOTAL OF 158 PATIENTS (AGE RANGE: 28 TO 92 YEARS; MALE:FEMALE RATIO OF 15:1) WERE TREATED WITH THE PHS AND WERE INCLUDED IN THE STUDY. DURING THE SURGICAL PROCEDURE, ALL PATIENTS WERE OPERATED WITH THE PROLENE HERNIA SYSTEM BILAYER (ETHICON). REPORTED COMPLICATIONS INCLUDED RECURRENT INGUINAL HERNIA (N-5), TESTICULAR ATROPHY (N-3), AND MILD CHRONIC PAIN (N-4). THE PHS TECHNIQUE HAS PREVIOUSLY SHOWN ACCEPTABLE SHORT-TERM RESULTS. THIS PROCEDURE IS CHARACTERISED BY A SHORT LEARNING CURVE, SHORT DURATION OF THE PROCEDURE, LOW COMPLICATION RATE AND IS APPLICABLE FOR ALL TYPES OF INGUINAL HERNIAS. THE PHS IS, THEREFORE, AN EXCEPTIONALLY FIT PROCEDURE TO IMPLEMENT IN A REGIONAL SURGICAL TRAINING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243540 PROLENE HERNIA SYSTEM UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention