BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEHS-COMPOSIX

    MDR report key: 2404112 · Received January 4, 2012

    Report

    Report Number
    1213643-2012-00005
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    November 5, 1999
    Report Date
    April 24, 2009
    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 COMPOSIX MESH OCCURRED, HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER DEVICE. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT HAS COMORBIDITIES INCLUDING EMPHYSEMA, CONGESTIVE HEART FAILURE AND A HISTORY OF (B)(6). ALTHOUGH THE MEDICAL RECORDS NOTE THE PATIENT WAS TREATED FOR A PERSISTENT INFECTION, THERE WERE NO CULTURE REPORTS PROVIDED TO CONFIRM THE PRESENCE OF THE 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, THE MESH WAS PARTIALLY EXCISED, AND NOT RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. SEE MDR 1213643-2009-00321 FOR INFORMATION RELATED TO THE OTHER COMPOSIX MESH IMPLANTED ON (B)(6) 1999.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 1999 - PATIENT UNDERWENT REPAIR OF MULTIPLE RECURRENT MASSIVE INCISIONAL HERNIAS WITH TWO PIECES OF COMPOSIX MESH AND A NON-BARD VICRYL MESH. ON (B)(6) 1999 - PATIENT HAS DRAINAGE, DRAIN REMOVED. ON (B)(6) 1999 - PATIENT HAVING DRAINAGE, POSSIBLE INFECTION. ON (B)(6) 1999 - WOUND DEHISCENCE, SUTURES APPEAR "TORN." PATIENT ADMITS TO CONSISTENT COUGHING. ON (B)(6) 1999 - WOUND DEHISCENCE, MESH EXPOSED, ANTIBIOTIC. ON (B)(6) 1999 - PATIENT UNDERWENT PARTIAL REMOVAL OF COMPOSIX MESH. THE UNDERSURFACE OF THE MESH WAS NOT INCORPORATED. ON (B)(6) 1999 - WOUND GRANULATING, CONTINUING ANTIBIOTICS. ON (B)(6) 1999 - WOUND NOT HEALING. ON (B)(6) 2000 - MESH STABILIZED, APPEARS CONTAMINATED, ATTEMPT TO CLOSE MESH TO SKIN. ON (B)(6) 2000 - WOUND CONTINUES LANGUISH AND HAS NO REAL SIGNS OF CLOSURE BUT DOES NOT LOOK INFECTED. ON (B)(6) 2000 - WOUND LOOKS FAIRLY GOOD, SUTURE REMOVED, DEBRIDEMENT OF MESH. ON (B)(6) 2001 - PATIENT HAS 5-6 LITTLE AREAS OF SPLITTING MESH OUT OF OLD INCISION. ON (B)(6) 2001 - POOR WOUND HEALING, NO RECURRENCE, INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEHS-COMPOSIX FTL DAVOL INC NA 41AJDP48

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention