BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIUM C-QUR EDGE MESH (PRODUCT #31233)

    MDR report key: 3267853 · Received April 19, 2008

    Report

    Report Number
    1219977-2008-00002
    Event Type
    Malfunction
    Date Received
    April 19, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 18, 2008
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATRIUM C-QUR MESH ADHERED TO BOWEL AND LEFT A WHITE, PASTY GLUE-LIKE FILM OVER THE BOWEL. DETAILS: A 6X8 PIECE OF ATRIUM C-QUR MESH WAS PLACED IN AN OPEN VENTRAL HERNIA REPAIR ON (B)(4) 2008. IT WAS NOT CUT AND IT WAS REPORTEDLY FIXATED WITH 8-10 SUTURES ON THE EDGE. THE PATIENT WAS DIABETIC AND THE INCISION WAS NOT HEALING WELL. THE PATIENT STRAINED AND OPENED THE STAPLES ON THE INCISION. HE CAME INTO THE HOSPITAL TO HAVE THE INCISION REPAIRED. SINCE THE WOUND WAS OPEN, DR. (B)(6) DECIDED HE NEEDED TO EXPLANT THE MESH AND REPLACE IT WITH ANOTHER PIECE OF CQUR SINCE IT WAS EXPOSED. WHEN HE WENT TO EXPLANT, HE REPORTED THAT ALL OF THE COATING HAD COME OFF IN SOME PLACES AND HE WAS CONCERNED SINCE IT HAD BEEN LESS THAN 30 DAYS. HE THOUGHT THE COATING WOULD STAY ON LONGER. THIS GAVE THE OPERATING ROOM STAFF THE IMPRESSION THAT THE MESH WAS DISINTEGRATING. DR.(B)(6) WAS ABLE TO DISSECT THE BOWEL FROM THE MESH WITHOUT MUCH PROBLEM, EXCEPT IN ONE AREA ALONG THE EDGE WHERE THE BOWEL WAS "VERY STUCK". NO HARM TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM C-QUR EDGE MESH (PRODUCT #31233) NONE FTL 10241117029

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other