BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7927658 · Received October 2, 2018

    Report

    Report Number
    2210968-2018-76226
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT INVOLVED? CITATION: INDIAN J SURG. 2014; 76(2): 124¿126. DOI: 10.1007/S12262-012-0646-X. (B)(4).

    Description of Event or Problem · 1

    TITLE: INGUINAL HERNIA REPAIR VIA APPLICATION OF MESH IN FRONT OF AND BEHIND THE FASCIA TRANSVERSALIS. AUTHORS: NURULLAH BÜLBÜLLER, ZIYA ÇETINKAYA, CÜNEYT KIRKIL, REFIK AYTEN, ERHAN AYGEN, MUSTAFA GIRGIN, YAVUZ SELIM ILHAN. CITATION: INDIAN J SURG. 2014; 76(2): 124¿126. DOI: 10.1007/S12262-012-0646-X. THE AIM OF THIS STUDY WAS TO COMPARE MESH PLACEMENT IN FRONT OF THE FASCIA TRANSVERSALIS AND BEHIND THE FASCIA TRANSVERSALIS VIA INGUINAL INCISION. THE AUTHORS EVALUATED THE RESULTS OF 106 INGUINAL HERNIA CASES (AGE RANGE: 19 TO 76 YEARS OLD) IN ALL MALE PATIENTS TREATED WITH PROLENE POLYPROPYLENE MESH (ETHICON) APPLIED VIA THE ANTERIOR OR POSTERIOR APPROACH BETWEEN DECEMBER 2004 AND JANUARY 2010. A KEYHOLE-SHAPED RECESS WAS MADE FOR PLACEMENT OF THE MESH ON THE PERITONEUM, AND THEREAFTER IT WAS AFFIXED TO THE COOPER¿S LIGAMENT. IT WAS SUTURED TO THE ILIOPUBIC TRACT AND THE TENDON CONJOINT FROM BEHIND USING PROLENE 2-0 SUTURES (ETHICON). THE EDGES OF THE FASCIA TRANSVERSALIS ABOVE THE MESH WERE ALSO SUTURED USING PROLENE 2-0 SUTURES (ETHICON). IN CASES OF DIRECT HERNIA THE HERNIA SAC WAS INVERTED WITHOUT BEING OPENED, AND AFTER MAKING A RECESS FOR THE MESH CORD AND PLACING ON THE FASCIA TRANSVERSALIS, IT WAS SUTURED TO THE INGUINAL LIGAMENT AND THE TENDON CONJOINT USING PROLENE 2-0 SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED HEMATOMA AT THE SITE OF THE INCISION (N-4) AND SEROMA (N-2). THE GOAL OF SURGICAL TREATMENT OF INGUINAL HERNIAS IS TO REDUCE THE RATE OF RECURRENCE. ONE OF THE MOST IMPORTANT FACTORS ASSOCIATED WITH RECURRENCE IS ANATOMIC STRUCTURES IN THE REGION THAT REMAIN UNDER TENSION. TENSION DID NOT OCCUR IN HERNIAS REPAIRED USING MESH. THERE WERE NO SIGNIFICANT DIFFERENCE IN THE SHORT- AND LONG-TERM OUTCOMES BETWEEN THE PATIENTS WHO UNDERWENT THE TWO HERNIA REPAIR METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768736 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention