BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH TSL - PERMACOL¿

    MDR report key: 9929383 · Received April 6, 2020

    Report

    Report Number
    9617613-2020-00048
    Event Type
    Death
    Date Received
    April 6, 2020
    Date of Event
    January 19, 2019
    Report Date
    April 6, 2020
    Manufacturer
    TISSUE SCIENCE LABORATORIES
    Product Code
    FTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: LESSONS LEARNED FROM 227 BIOLOGICAL MESHES USED FOR THE SURGICAL TREATMENT OF VENTRAL ABDOMINAL DEFECTS SOURCE: ARTICLE: N. BALDAN. 20Q8, PUBLISHED ONLINE: 19 JANUARY 2019 © SPRINGER-VERLAG FRANCE SAS, PART OF SPRINGER NATURE 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, FROM JANUARY 2010 TO MARCH 2016, A TOTAL OF 227 PATIENTS WHOSE VENTRAL ABDOMINAL DEFECTS WERE RECONSTRUCTED WITH A BIOLOGICAL MESH WERE INCLUDED IN THE STUDY, AND THE DEVICE WAS USED IN 94 OF THE CASES. PATIENTS WERE DIVIDED ACCORDING TO THE 2010 FOUR-LEVEL SURGICAL-SITE COMPLICATION RISK GRADING SYSTEM PROPOSED BY THE VENTRAL HERNIA WORKING GROUP (VHWG): GRADE 1 (G1, 12 CASES), GRADE 2 (G2, 68 CASES), GRADE 3 (G3, 112 CASES), AND GRADE 4 (G4, 35 CASES). IT WAS ALSO REPORTED THAT 11 PATIENTS DIED FROM THE HIGH-RISK VHWG GROUP (GRADES 3 AND 4). DEATH WAS DUE TO CARDIOVASCULAR OR RESPIRATORY COMPLICATIONS (3 CASES), MULTIPLE ORGAN FAILURE (4 CASES), SEPSIS (3 CASES), OR ACUTE NECROTIZING PANCREATITIS (1 CASE). THE TYPES OF MESH THE PATIENTS HAD IMPLANTED WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394197 MESH TSL - PERMACOL¿ MESH, SURGICAL FTM TISSUE SCIENCE LABORATORIES UNK-PERMACOL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death