BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR HERNIA MESH

    MDR report key: 4426169 · Received January 10, 2015

    Report

    Report Number
    MW5040226
    Event Type
    Injury
    Date Received
    January 10, 2015
    Date of Event
    March 9, 2011
    Report Date
    January 10, 2015
    Manufacturer
    ATRIUM
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, I UNDERWENT A REPAIR OF VENTRAL HERNIA AND REMOVAL OF GIST, ATRIUM'S C-QUR HERNIA MESH WAS INSTALLED. SOMETIMES THEREAFTER, THE C-QUR MESH BECAME INTERTWINED WITH MY INTESTINES, BOWEL, AND ADHERED TO MY COLON. APPROX SEVENTEEN MONTHS LATER, ON (B)(6), 2012, I UNDERWENT AN OPEN REPAIR OF THE INCARCERATED MESH. MOST RECENTLY, ON (B)(6), 2014, I HAD TO UNDERGO YET ANOTHER OPEN REPAIR OF AN INCARCERATED INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24227 C-QUR HERNIA MESH C-QUR HERNIA MESH FTL ATRIUM

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention