BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8951460 · Received August 30, 2019

    Report

    Report Number
    2210968-2019-86453
    Event Type
    Injury
    Date Received
    August 30, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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: 113¿116; DOI 10.1007/S10029-003-0179-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PREPERITONEAL REPAIR FOR RECURRENT INGUINAL HERNIA: LAPAROSCOPIC AND OPEN APPROACH. THE AIM OF THIS PROSPECTIVE CONTROLLED NONRANDOMIZED CLINICAL STUDY WAS TO INVESTIGATE THE OUTCOME OF PREPERITONEAL REPAIR USING LAPAROSCOPIC EXTRAPERITONEAL REPAIR (TEP) AND OPEN PREPERITONEAL MESH REPAIR (OPM) APPROACH IN RECURRENT INGUINAL HERNIA. FROM JANUARY 1995 ¿ DECEMBER 1999, 188 PATIENTS WERE OPERATED ON FOR RECURRENT INGUINAL HERNIA IN WHICH THE PATIENTS WERE DIVIDED INTO TWO GROUPS: OPM (N=110, MALE=105, FEMALE=5) AND TEP (N=78, MALE=77, FEMALE=1); THE MEAN AGE OF THESE PATIENTS WAS 57 YEARS (AGE RANGE 21-80 YEARS). OPM WAS UNDERTAKEN THROUGH A LOWER ABDOMINAL TRANSVERSE INCISION, THE ANTERIOR RECTUS SHEATH WAS INCISED AND THE MUSCLE REFLECTED MEDIALLY. THE PREPERITONEAL SPACE WAS CLEAVED WITH BLUNT DISSECTION, EXPOSING THE MYOPECTINEAL ORIFICE. THE HERNIA WAS REDUCED AND NOT REPAIRED. A 15 X 15 CM POLYPROPYLENE MESH, WITHOUT SLITS, (ETHICON) WAS INSERTED IN THE PREPERITONEAL SPACE, PARIETALIZING THE SPERMATIC-CORD ELEMENTS, AND FIXED WITH NONABSORBABLE SUTURES. POSTOPERATIVE COMPLICATIONS WITH OPM GROUP INCLUDED HAEMATOMA (N=10); WOUND INFECTION (N=2); SEROMA (N=3); INGUINAL NEURALGIA (N=5); PAINFUL TESTICLE (N=2); AND RECURRENCE (N=2). PREPERITONEAL APPROACH (OPEN OR LAPAROSCOPIC) SEEMS TO BE A GOOD OPTION IN RECURRENT INGUINAL HERNIA WHEN THESE PROCEDURES ARE DONE BY EXPERIENCED SURGEONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745304 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention