BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR TACSHIELD

    MDR report key: 2963687 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00211
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    January 31, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A SMALL PORTION OF THE EXPLANT WAS RETURNED. THE STITCHING AROUND THE PERIMETER OF THE PATCH WAS INTACT AND THERE WERE NO RIPS OR TEARS NOTED IN THE SAMPLE SECTION RETURNED, EXCEPT WHERE CUT BY THE SURGEON DURING EXPLANT. THERE WAS ONE SUTURE AND ONE TACK VISIBLE IN THE TOP LAYER OF MESH THAT MAKES UP THE APRON OF THE MESH. THERE WAS VERY LITTLE COATING VISIBLE ON THE VISCERAL SIDE OF THE MESH. THERE APPEARED TO BE SIGNIFICANT TISSUE INGROWTH INTO THE ENTIRE TOP LAYER (APRON) OF THE PATCH, AS THE MESH CONSTRUCTION AND PORES WERE HARDLY DISCERNABLE. ON THE VISCERAL SIDE OF THE PATCH, TISSUE INGROWTH WAS LIMITED TO THE PERIMETER OF THE PATCH NEAR THE STITCHING, WHILE SUBSTANTIALLY LESS TISSUE WAS NOTED TOWARDS THE CENTER OF THE PATCH. THE LACK OF COMPLETE TISSUE INCORPORATION THROUGH BOTH LAYERS OF MESH IS MOST LIKELY DUE TO THE SEROMA AND INFECTION. POST-OPERATIVE SEROMA FORMATION AFTER HERNIA REPAIR IS VERY COMMON. IT HAS BEEN REPORTED THAT APPROXIMATELY 1/3 OF HERNIA REPAIRS SHOW CLINICALLY EVIDENT SEROMA FORMATION AND AS MANY AS 100% OF CASES EXHIBIT SEROMAS WHEN EXAMINED BY ULTRASOUND. POST-OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS ALSO A COMMON OCCURRENCE AND THE RATE OF INFECTION CAN BE INFLUENCED BY A VARIETY OF SURGICAL AND PATIENT FACTORS. THE RATE OF INFECTION IS KNOWN TO BE INCREASED DURING OPEN HERNIA REPAIRS, AND IN PATIENTS WHO ARE IMMUNOSUPPRESSED, SMOKERS, DIABETIC, AND/OR OBESE. THE LOT HISTORY AND STERILIZATION RECORDS OF THIS LOT OF MESH WERE EXAMINED AND NO DEVIATIONS WERE NOTED. A DEFINITIVE CAUSE OF THE SEROMA AND SUBSEQUENT INFECTION IN THIS CASE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED; HOWEVER, THERE ARE NO REASONS TO CONCLUDE THAT THIS C-QUR TACSHIELD MESH DEVICE ITSELF WAS THE ROOT CAUSE OF THE SEROMA OR INFECTION IN THIS CASE.

    Description of Event or Problem · 1

    PATIENT HAD CHRONIC SEROMA AND SUBSEQUENTLY THE MESH BECAME INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980 C-QUR TACSHIELD FTL ATRIUM MEDICAL CORP. 31626 10698739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention