BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CQUR MESH

    MDR report key: 2963677 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00230
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    July 27, 2012
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED IN FORMALIN FIXATIVE AND WAS ODOROUS WHEN REMOVED FROM ITS EXTERNAL PACKAGING, THEREFORE, DID NOT UNDERGO A FULL EVALUATION. THE LOT HISTORY FOR THIS LOT OF C-QUR MESH WAS REVIEWED AND NO DEVIATIONS IN THE MANUFACTURING OR STERILIZATION PROCESSES WERE NOTED. POST-OPERATIVE SEROMA FORMATION AFTER HERNIA REPAIR IS VERY COMMON. IT HAS BEEN REPORTED THAT APPROXIMATELY (B)(4) OF HERNIA REPAIRS SHOW CLINICALLY EVIDENT SEROMA FORMATION AND AS MANY AS (B)(4) OF CASES EXHIBIT SEROMAS WHEN EXAMINED BY ULTRASOUND. BASED ON REVIEW OF THE LOT HISTORY FILES, THERE ARE NO REASONS TO CONCLUDE THAT THE C-QUR MESH WAS THE ROOT CAUSE OF THE SEROMA FORMATION NOTED WITH THIS PT.

    Description of Event or Problem · 1

    MESH WAS IMPLANTED ON (B)(6) 2011. THE PT DEVELOPED A SEROMA, WHICH WAS DRAINED SEVERAL TIMES. THE LAST DRAINAGE OF SEROMA INVOLVED OPENING PRECIOUS INCISION, DRAINING FLUID, SPRAYING INTERNAL TALC AND PUTTING IN 4 WOUND DRAINS. DESPITE THIS, PT DEVELOPED ANOTHER SEROMA AND SURGEON DECIDED TO EXPLANT MESH AND USE A PORCINE MESH INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422 CQUR MESH FTL ATRIUM MEDICAL CORP 31536 10554649

    Patients

    Seq Age Sex Outcome Treatment
    1 Other