BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM C-QUR MESH

    MDR report key: 5341346 · Received December 28, 2015

    Report

    Report Number
    MW5058864
    Event Type
    Injury
    Date Received
    December 28, 2015
    Date of Event
    November 13, 2013
    Report Date
    December 28, 2015
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH ATRIUM C-QUR MESH FOR REPAIR OF INGUINAL HERNIA, APPROX, ONE YEAR LATER, MY BODY REJECTED THE ATRIUM C-QUR MESH REQUIRING REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853418 ATRIUM C-QUR MESH ATRIUM C-QUR MESH FTL ATRIUM MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| L| R