BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM- PARIETEX COMPOSITE MESH

    MDR report key: 12375443 · Received August 26, 2021

    Report

    Report Number
    9615742-2021-02097
    Event Type
    Injury
    Date Received
    August 26, 2021
    Report Date
    August 26, 2021
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: DEVICE FIXATION HERNIA PERMASORB DAVOL/BARD DAVOL - MODEL/CAT # 0113092, LOT # CVUG0606; DEVICE FIXATION HERNIA PERMASORB DAVOL/BARD DAVOL - MODEL/CAT # 0113092, LOT # CVUG0606. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, FAILURE OF MESH, INFECTION, INFLAMMATION, AND FOREIGN BODY GRANULOMAS REACTION. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MESH REVISION SURGERY, AND MESH REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272327 MESH SOFRADIM- PARIETEX COMPOSITE MESH MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO1510 PKH00082

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention