BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PARIETEX

    MDR report key: 8733285 · Received June 26, 2019

    Report

    Report Number
    9615742-2019-02288
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 28, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE LONG-TERM RESULTS AFTER LAPAROSCOPIC REOPERATION FOR FAILED ANTIREFLUX PROCEDURES SOURCE BRITISH JOURNAL OF SURGERY, VOLUME 98, 2011 (1581-1587) DATE OF PUBLICATION: 28 JUNE 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (YEAR 7 APRIL 2011 TO 28 JUNE 2011), THIS STUDY AIMED TO EVALUATE THE LONG-TERM SUBJECTIVE AND OBJECTIVE OUTCOMES IN PATIENTS WHO UNDERWENT LAPAROSCOPIC SURGERY FOR FUNDOPLICATION FAILURE. PATIENTS WERE TREATED WITH PARIETEX COMPOSITE MESH OR SURGISIS BIOLOGICAL MESH. COMPLICATIONS WERE NOT REPORTED SEPARATELY BASED ON MESH TYPE BUT RATHER ALL COMPLICATIONS WERE AGGREGATED. TWO CONVERSIONS TO OPEN OPERATION WERE NEEDED OWING TO DENSE ADHESIONS PREVENTING SUCCESSFUL PROGRESS LAPAROSCOPICALLY. AN ADVERSE EVENT THAT OCCURRED THAT REQUIRED TREATMENT INCLUDE, FISTULA FROM THE CARDIA, LEAK FROM A PYLOROMYOTOMY SITE, EARLY MIGRATION OF THE WRAP, PLEURAL EFFUSION, PULMONARY INFECTION, CARDIAC ARRHYTHMIA LONG-TERM RESULTS AFTER LAPAROSCOPIC REOPERATION FOR FAILED ANTIREFLUX PROCEDURES / B. DALLEMAGNE1, M. ARENAS SANCHEZ2, D. FRANCART2, S. PERRETTA1, J. WEERTS2, S. MARKIEWICZ2 AND C. JEHAES2 / BRITISH JOURNAL OF SURGERY 2011; 98: 1581¿1587.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530361 UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R