BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8915693 · Received August 21, 2019

    Report

    Report Number
    2210968-2019-85927
    Event Type
    Injury
    Date Received
    August 21, 2019
    Report Date
    July 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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: HERNIA (2004) 8: 127¿134 / DOI 10.1007/S10029-003-0192-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: EARLY RESULTS OF A SINGLE-BLINDED, RANDOMIZED, CONTROLLED, INTERNET-BASED MULTICENTER TRIAL COMPARING PROLENE AND VYPRO II MESH IN LICHTENSTEIN HERNIOPLASTY. THE PURPOSE OF THIS SINGLE-BLINDED, RANDOMIZED, CONTROLLED, INTERNET-BASED MULTICENTER TRIAL WAS TO COMPARE A STANDARD POLYPROPYLENE MESH WITH THE NEW POLYPROPYLENE/POLYGLACTIN MESH IN THE LICHTENSTEIN OPERATION. FROM DEC 2000 TO AUG 2002, A TOTAL OF 591 MALE PATIENTS, MORE THAN 25 YEARS OF AGE, WITH A UNILATERAL PRIMARY INGUINAL HERNIA WERE ELIGIBLE TO PARTICIPATE IN THE STUDY. THE PATIENTS WERE RANDOMIZED TO LICHTENSTEIN¿S OPERATION WITH EITHER: PROLENE MESH GROUP (N=295, MEAN AGE 54 YEARS) OR VYPRO II MESH GROUP (N=296, MEAN AGE 55 YEARS). A PIECE OF 7.5 X 15-CM PROLENE (ETHICON) OR VYPRO II (ETHICON) MESH WAS USED ACCORDING TO THE ASSIGNED GROUP. POSTOPERATIVE COMPLICATIONS INCLUDED PROLONGED POSTOPERATIVE PAIN OR NEURALGIA (N=9, N=7 FROM PROLENE, N=2 FROM VYPRO II); SEROMA (N=5, N=2 FROM PROLENE, N=3 FROM VYPRO II); HEMATOMA (N=25, N=11 FROM PROLENE, N=14 FROM VYPRO II) WHICH ONE PATIENT NEEDED REOPERATION WITH EVACUATION OF THE HEMATOMA ON THE DAY OF THE OPERATION UNDER VYPRO II GROUP; URINARY TRACT INFECTION (N=1); TESTIS ATROFIA (N=1); SENSORY LOSS (N=3, N=2 FROM PROLENE, N=1 FROM VYPRO II); URINARY RETENTION (N=1); AND ISCHEMIC ORCHITIS (N=1). LICHTENSTEIN¿S OPERATION WITH EITHER PROLENE OR VYPRO II IS SAFE AND WELL TOLERATED WITH AN ACCEPTABLE POSTOPERATIVE REHABILITATION TIME AND A HIGH QUALITY OF LIFE 2 MONTHS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707629 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention