BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR

    MDR report key: 2963720 · Received January 2, 2013

    Report

    Report Number
    1219977-2012-00201
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    April 22, 2011
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION OBTAINED FROM THE SURGEON INDICATED THAT THE MESH WAS ORIGINALLY IMPLANTED 2 YEARS AGO PRIOR TO THE EXPLANT DATE, NOT 1 YEAR AGO AS ORIGINALLY STATED, VIA AN OPEN REPAIR OF A LARGE VENTRAL HERNIA AND THAT THE DEFECT WAS CLOSED OVER THE MESH DURING THE REPAIR. THE SURGEON INDICATED THAT THE PT HAD NO HISTORY OF INFECTION PRIOR TO THIS INFECTION WHICH WAS CULTURED AND DETERMINED TO BE A STRAIN OF STAPHYLOCOCCUS BACTERIA. THE SURGEON NOTED THAT UPON EXPLANT, THE MESH HAD GROWN INTO THE ABDOMINAL WALL SO THOROUGHLY THAT SECTIONS OF THE ABDOMINAL WALL MUSCULATURE NEEDED TO BE RESECTED. THE LOT HISTORY AND STERILIZATION RECORDS OF THIS LOT OF C-QUR MESH WERE REVIEWED AND NO DEVIATIONS WERE FOUND. POST-OPERATIVE INFECTION AFTER HERNIA REPAIR USING MESH IS A COMMON OCCURRENCE AND THE RATE OF INFECTION CAN BE INFLUENCED BY A VARIETY OF FACTORS. INFECTION RATES AFTER OPEN REPAIR OF VENTRAL/INCISIONAL HERNIAS HAVE BEEN REPORTED TO BE (B)(4). THE FOLDING OF THE MESH AS SEEN IN THE PHOTOGRAPHS, MAY HAVE PROVIDED AN AREA FOR BACTERIA TO RESIDE HIDDEN FROM THE PT'S IMMUNE SYSTEM. SURGICAL IMPLANTATION TECHNIQUE AND FIXATION ARE CRITICAL IN PREVENTING ALL HERNIA REPAIR MESHES FROM FOLDING AND BUCKLING. THE FOLDING EXHIBITED IN THIS EXPLANT INDICATES THAT THE IMPLANT MAY NOT HAVE BEEN COMPLETELY FLAT DURING FIXATION OR THAT THE FIXATION WAS NOT ADEQUATE, ALLOWING THE MESH TO FOLD, POTENTIALLY PROVIDING AREAS FOR BACTERIAL INFECTION TO OCCUR HIDDEN FROM THE PT'S IMMUNE SYSTEM.

    Description of Event or Problem · 1

    EXPLANTED DUE TO INFECTION, RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560 C-QUR FTL ATRIUM MEDICAL CORP. 31538 10554633

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention