BEUDAMED
    FDA Adverse Event Death Summary report: N

    C-QUR MESH

    MDR report key: 2648423 · Received July 2, 2012

    Report

    Report Number
    2648423
    Event Type
    Death
    Date Received
    July 2, 2012
    Date of Event
    June 17, 2012
    Report Date
    June 28, 2012
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT FOUND TO HAVE INFECTED SURGICAL MESH DURING EXPLORATORY LAPAROTOMY PERFORMED ON (B)(6) 2012. SURGICAL MESH WAS PLACED (B)(6) 2009, FOR HERNIA REPAIR. SURGEON UNABLE TO FULLY EXTRACT INFECTED MESH WHICH CAUSED OR CONTRIBUTED TO A SIGNIFICANT SMALL BOWEL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-QUR MESH ABDOMINAL MESH FTL ATRIUM MEDICAL CORPORATION 31237 10420136019

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death