BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7929816 · Received October 3, 2018

    Report

    Report Number
    2210968-2018-76258
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    September 10, 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. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: HERNIA. 2015; 19: 383¿387. DOI: 10.1007/S10029-015-1350-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: PROSPECTIVE RANDOMIZED CLINICAL TRIAL OF JEAN RIVES TECHNIQUE VERSUS LAPAROSCOPIC TEP REPAIR FOR PRIMARY INGUINAL HERNIA: 10-YEAR FOLLOW-UP" AUTHORS: K. TOMAOGLU, Y. S. SARI, H. BEKTAS, O. KOC, E. GUNES, G. UZUM, M. KUCUKYILMAZ CITATION: HERNIA. 2015; 19: 383¿387. DOI: 10.1007/S10029-015-1350-0. THE PURPOSE OF THE PRESENT RANDOMIZED TRIAL WAS TO COMPARE THE JEAN RIVES (JR) TECHNIQUE AND THE LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) REPAIR FOR THE TREATMENT OF PRIMARY INGUINAL HERNIAS WITH RESPECT TO OPERATING TIME, HOSPITAL STAY, SICK LEAVE, CHRONIC PAIN, AND RECURRENCES AFTER A FOLLOW-UP OF 10 YEARS. A TOTAL OF 110 PATIENTS WITH PRIMARY INGUINAL HERNIA WERE RANDOMIZED TO EITHER A JR REPAIR (53 PATIENTS; MEAN AGE: 40.54 ± 4.52) OR TO A LAPAROSCOPIC TEP REPAIR (57 PATIENTS; MEAN AGE: 41.19 ± 2.82) AND WERE INCLUDED IN THE STUDY. DURING THE JR REPAIR PROCEDURE, THE SYNTHETIC PROSTHESIS, PROLENE MESH (ETHICON) OF 12 × 8 CM DIMENSIONS WAS ARRANGED IN THE PREPERITONEAL SPACE SO THAT THE MATERIAL STRETCHES TRANSVERSELY AND FIXED INFERIORLY TO THE COOPER¿S LIGAMENT BY THREE APPLICATIONS OF TACKER. THE MESH WAS FIXED MEDIALLY TO THE POSTERIOR FACE OF RECTUS MUSCLE AND LATERALLY TO THE INGUINAL LIGAMENT BY PROLENE 0 NON-ABSORBABLE SUTURES (ETHICON). IN THE JR GROUP, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE WOUND INFECTION (N-1), CHRONIC PAIN (N-2), AND RECURRENCES (N-2). IT WAS REPORTED THAT THE LONG-TERM RESULTS HAS BROUGHT TO LIGHT THAT THE TEP TECHNIQUE AND THE JR TECHNIQUE WERE EQUALLY EFFICIENT. THE JR TECHNIQUE WAS SIGNIFICANTLY ADVANTAGEOUS IN TERMS OF OPERATING TIME. THE JR TECHNIQUE IS A RELATIVELY EASY TECHNIQUE TO PERFORM, REQUIRES SHORTER OPERATING TIME WHEN COMPARED TO LAPAROSCOPIC TEP TECHNIQUE. JR TECHNIQUE SHOULD BE TAKEN INTO CONSIDERATION WHILE PLANNING SURGICAL TREATMENT OF INGUINAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771459 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROLENE SUTURE