BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH

    MDR report key: 8987793 · Received September 11, 2019

    Report

    Report Number
    9615742-2019-03043
    Event Type
    Injury
    Date Received
    September 11, 2019
    Report Date
    September 11, 2019
    Manufacturer
    SOFRADIM PRODUCTION SAS
    Product Code
    FTL
    PMA / PMN Number
    K040998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 UMBILICAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED ADDITIONAL IMPLANT AND REVISION SURGERY. THE DEVICE HAD BEEN USED WITH A BARD MESH PERFIX PLUG (0112990, LOT# HUTD0480).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785496 MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC FTL SOFRADIM PRODUCTION SAS PCO9 PJD00337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BARD MESH PERFIX PLUG 0112990 (LOT# HUTD0480)