BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 2150607 · Received June 23, 2011

    Report

    Report Number
    1213643-2011-00305
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    January 27, 2003
    Report Date
    July 27, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY, THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A ONE COMPOSIX MESH OCCURRED; HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER EVENT. BASED ON THE MEDICAL RECORD REVIEW, THE PT UNDERWENT VENTRAL HERNIA REPAIR WITH TWO COMPOSIX MESHES. ON (B)(6) 2002, THE PT PRESENTED TO THE ER NOTING PUS EXTRUDING FROM HER ABDOMINAL WOUND. SUBSEQUENTLY, THE PT UNDERWENT EXPLORATION OF THE ABDOMINAL WOUND. THE COMPOSIX MESH WAS IDENTIFIED AND THE MEDICAL RECORDS NOTE A TRACK WHICH SCREWED INTO THE MESH ITSELF WAS SEEN. THE SUPERIOR PART OF THE MESH WAS NOT INCORPORATED DUE TO THE PRESENCE OF AN INFECTION AND THEREFORE, A PARTIAL EXPLANT WAS PERFORMED. DUE TO THE INABILITY TO CONTROL AN INFECTION, THE PT UNDERWENT EXCISION OF THE COMPOSIX MESH ON (B)(6) 2003. SINCE TWO PIECES OF COMPOSIX MESH WERE IMPLANTED, THERE IS NO WAY TO DETERMINE WHICH MESH WAS EXPLANTED ON WHICH DATE. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR AN INFECTION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2010-00147 FOR INFO RELATED TO THE ADDITIONAL COMPOSIX MESH IMPLANTED ON (B)(6) 2002.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2002 - PT UNDERWENT REPAIR OF VENTRAL HERNIA WITH TWO PIECES OF COMPOSIX MESH. ON (B)(6) 2002 - PT ADMITTED TO ER WITH THE PRESENCE OF PUS EXTRUDING FROM HER WOUND. ON (B)(6) 2002 - PT UNDERWENT EXPLORATION OF ABDOMINAL WALL WOUND. ONCE THE MESH WAS IDENTIFIED, THE MEDICAL RECORDS NOTE A TRACK WHICH SCREWED INTO THE MESH ITSELF. THE SUPERIOR PART OF THE MESH WAS NOT INCORPORATED INTO THE TISSUE DUE TO THE INFECTION, THIS PART OF THE MESH WAS EXCISED. ON (B)(6) 2003 - PT UNDERWENT INCISIONAL HERNIA REPAIR; NO MESH NOTED. DUE TO THE PRESENCE OF AN INFECTION, THE COMPOSIX MESH WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC. NA 43DMD032

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R