BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX PRODUCT

    MDR report key: 8733254 · Received June 26, 2019

    Report

    Report Number
    9615742-2019-02296
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    May 20, 2009
    Report Date
    June 25, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: LONG-TERM RESULTS OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS USING AN INTRAPERITONEAL COMPOSITE MESH / ALFREDO MORENO-EGEA Æ JOSE´ ANTONIO CASTILLO BUSTOS Æ ENRIQUE GIRELA Æ JOSE´ LUIS AGUAYO-ALBASINI / SOURCE: 27 JANUARY 2009 / ACCEPTED: 20 MAY 2009 / PUBLISHED ONLINE: 17 JUNE 2009 SPRINGER SCIENCE+BUSINESS MEDIA, LLC 2009. 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, (JANUARY 1994 AND DECEMBER 2006), THIS STUDY AIMED TO EVALUATE THE LONG-TERM COMPLICATIONS AND RECURRENCES OF LAPAROSCOPIC REPAIR OF INCISIONAL HERNIAS. DATA FOR 200 CONSECUTIVE PATIENTS WHO UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR (LIHR) IN A UNIVERSITY TEACHING HOSPITAL ERE COLLECTED PROSPECTIVELY. THE MEDIAN FOLLOW-UP WAS 6 (RANGE, 1¿12) YEARS. A DOUBLE-LAYER MESH WAS USED IN ALL CASES. ONE PATIENT HAD AN INTESTINAL INJURY WHICH DIAGNOSED DURING THE IMMEDIATE POSTOPERATIVE PERIOD AND REOPERATION WAS PERFORMED DUE TO ABDOMINAL SEPSIS. DURING THE OPERATION AN INTESTINAL RESECTION WAS PERFORMED AND THE PATCH WAS REMOVED. THE PATIENT PROGRESSED TO MULTIPLE ORGAN FAILURE AND DIED AS A RESULT OF A SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529692 UNKNOWN PARIETEX PRODUCT MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention