BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBOTEX MESH

    MDR report key: 8495982 · Received April 9, 2019

    Report

    Report Number
    9615742-2019-01128
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    July 1, 2018
    Report Date
    April 9, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: PRELIMINARY RESULTS ABOUT A NOVEL TECHNIQUE OF MESH POSITIONING IN THE ABDOMINAL WALL HERNIA REPAIR SOURCE: G CHIR VOL. 39 - N. 4 - PP. 223-226. DATE PUBLISHED: JULY-AUGUST 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY, IT SHOWED THE RESULTS OF A DIFFERENT MESH POSITIONING TECHNIQUE IN THE INTRAPERITONEAL ONLAY MESH MEDIATED ABDOMINAL WALL HERNIA REPAIR USING DUAL-MESH PROSTHESIS DEFINED ¿PERCUTANEOUS TECHNIQUE POSITIONING¿ INSTEAD OF THE CLASSIC POSITIONING TECHNIQUE. FOR ALL SURGICAL OPERATION, A THREE-DIMENSIONAL (3D) TEXTILE MONOFILAMENT POLYESTER (PET) MESH WITH BIOABSORBABLE COLLAGEN FILM WAS USED . FIXATION DEVICE WAS ALSO USED. THERE WERE 18 POSTOPERATIVE COMPLICATIONS WHICH INCLUDES WOUND INFECTION (5), HEMATOMA (5), SEROMA (7) AND RECURRENCE (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290113 SYMBOTEX MESH MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other