BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH TSL - PERMACOL¿

    MDR report key: 9910822 · Received April 1, 2020

    Report

    Report Number
    9615742-2020-00764
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 1, 2020
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPLANTATION OF BIOLOGIC MESH IN VENTRAL HERNIA REPAIR - DOES IT MAKE SENSE? / SOURCE: ABDELKADER TAIBI1,2 · SOPHIANE DERBAL1 · SYLVAINE DURAND FONTANIER1,2 / VISCERAL SURGERY DEPARTMENT, LIMOGES UNIVERSITY HOSPITAL, LIMOGES, FRANCE / RECEIVED: 8 AUGUST 2019 / ACCEPTED: 10 FEBRUARY 2020 / SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2020 / HTTPS://DOI.ORG/10.1007/S00464-020-07435-5. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, (FEBRUARY 2009-FEBRUARY 2015 ) THIS STUDY AIMED TO EVALUATE THE OUTCOMES OF IMPLANTATION OF BIOLOGIC MESH IN VENTRAL HERNIA REPAIR. 68 PATIENTS WITH INCISIONAL HERNIA THAT WERE IMPLANTED WITH BIOLOGICAL MESH, AND IT WAS REPORTED THAT 42 HAD AN ISSUE OF RECURRENCE, AND 7 REQUIRED REPLACEMENT OF A NEW MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376402 MESH TSL - PERMACOL¿ MESH, SURGICAL FTM SOFRADIM PRODUCTION SAS UNKNOWN PERMACOL PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention