BEUDAMED
    FDA Adverse Event Death Summary report: N

    C-QUR EDGE

    MDR report key: 2685202 · Received August 2, 2012

    Report

    Report Number
    1219977-2012-00016
    Event Type
    Death
    Date Received
    August 2, 2012
    Date of Event
    June 17, 2012
    Report Date
    August 2, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K080691
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UF REPORT RECEIVED FROM FDA (B)(6) 2012. NO UF REF. # SEVERAL ATTEMPTS WERE MADE TO REQUEST ADDITIONAL INFO FROM UF. CONTACT WAS MADE ON 07/27/2012 BY PHONE. UF CONTACT SAID THE EXPLANTED MESH WAS SENT TO PATHOLOGY AND HE WAS NOT AWARE OF ANY SAMPLE THAT WE MAY BE ABLE TO OBTAIN. THE PT'S MEDICAL NOTES AND THE PATHOLOGY REPORT WERE RECEIVED ON 07/30/2012 VIA EMAIL FROM UF. THE NOTES AND REPORT ARE CURRENTLY BEING REVIEWED BY A MEDICAL PROFESSIONAL. A F/U MEDWATCH WILL BE SENT UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PT FOUND TO HAVE INFECTED SURGICAL MESH DURING EXPLORATORY LAPAROTOMY PERFORMED ON (B)(6) 2012 (CORRECTED FROM UF REPORT). 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 EDGE ABDOMINAL MESH FTL ATRIUM MEDICAL CORP. 31237 10420136

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death