BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX

    MDR report key: 8733289 · Received June 26, 2019

    Report

    Report Number
    9615742-2019-02289
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 19, 2011
    Report Date
    June 25, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE RANDOMIZED CLINICAL TRIAL OF FIBRIN SEALANT VERSUS TITANIUM TACKS FOR MESH FIXATION IN LAPAROSCOPIC UMBILICAL HERNIA REPAIR. SOURCE BRITISH JOURNAL OF SURGERY, 98, 20181(1537-1545) DATE OF PUBLICATION: 24 AUGUST 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, AFTER LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH CONVENTIONAL MESH FIXATION USING TITANIUM TACKS, PATIENTS EXPERIENCED POSTOPERATIVE ACUTE PAIN. FORTY PATIENTS WERE INCLUDED, OF WHOM 38 WERE AVAILABLE FOR INTENTION-TO-TREAT ANALYSIS AFTER 1 MONTH. A 12-CM ROUND MESH WAS USED FOR ALL OPERATIONS AND TACK FIXATION DEVICE WAS USED FOR 19 PATIENTS WITH TACKS PLACED 1¿2 CM APART IN A DOUBLE-CROWN FASHION. COMPLICATIONS SUCH SEROMA, HEMATOMA, SUPERFICIAL INFECTION AND SKIN ERYTHEMA WERE REPORTED. RE-ADMISSION OF PATIENTS WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530365 UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other