BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR

    MDR report key: 2963719 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00203
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    March 30, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K080688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH HC-QUR V-PATCH EXPLANTS WERE EXAMINED CLOSELY AFTER REMOVAL FROM THEIR 10% FORMALIN CONTAINERS. THE STITCHING AROUND THE TAILS AND PERIMETER OF BOTH PATCHES WAS INTACT AND THERE WERE NO RIPS OR TEARS NOTED IN EITHER SAMPLE. THE TAILS ON BOTH PATCHES HAD BEEN CUT OFF AS INSTRUCTED IN THE PRODUCT IFU. THE REMNANTS OF THE TAILS WERE VISIBLE. THERE WAS SOME BUCKLING AND FOLDING OF BOTH OF THE PATCHES AND VERY LITTLE TISSUE INGROWTH WAS NOTED IN ASSOCIATION WITH EITHER EXPLANT, LIKELY DUE TO THE PRESENCE OF INFECTION. POST-OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS A COMMON OCCURRENCE AND THE RATE OF INFECTION CAN BE INFLUENCED BY A VARIETY OF SURGICAL AND PT FACTORS. THE RATE OF INFECTION IS KNOWN TO BE INCREASED DURING OPEN HERNIA REPAIRS, SUCH AS THOSE PERFORMED WHEN PLACING C-QUR V-PATCH MESH, AND IN PTS WHO ARE IMMUNOSUPPRESSED, SMOKERS, DIABETIC, AND/OR OBESE.

    Description of Event or Problem · 1

    EXPLANTED DUE TO INFECTION, RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438 C-QUR FTL ATRIUM MEDICAL CORP. 31200; 31201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention