BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH- COMPOSIX

    MDR report key: 2834117 · Received November 8, 2012

    Report

    Report Number
    1213643-2012-00780
    Event Type
    Death
    Date Received
    November 8, 2012
    Date of Event
    July 26, 2011
    Report Date
    October 12, 2012
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT DEVELOPED A FISTULA AND ABSCESS NEARLY SEVEN YEARS POST IMPLANT. THE MEDICAL RECORDS NOTE THAT A SMALL OPENING IN THE BOWEL WAS DRAINING INTO A POCKET. THE COMPOSIX MESH WAS NOTED TO BE INFECTED AND WAS REMOVED. TEN MONTHS AFTER THE REMOVAL OF THE COMPOSIX MESH, THE PT EXPIRED. THE CAUSE OF DEATH IS LISTED AS PNEUMONIA, SEPSIS AND MULTIPLE MYELOMA. THE INFORMATION 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, FISTULA AND ABSCESS ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. NO SAMPLE WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S SON: ON (B)(6) 2004- PT UNDERWENT REPAIR OF A RIGHT UPPER QUADRANT INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL MESH. THE COMPOSIX KUGEL MESH WAS SECURED AND THEN THE SURGEON WAS INFORMED BY THE NURSE THAT THE MESH WAS EXPIRED. THE SURGEON REMOVED THE MESH AND PLACED A COMPOSIX MESH. ON (B)(6) 2011- PT UNDERWENT REMOVAL OF COMPOSIX MESH. THE OPERATIVE DICTATION NOTES UPON OPENING THE ABSCESS THERE WAS A BOWEL SMELLING DRAINAGE AND THE COMPOSIX MESH WAS INFECTED. A SMALL OPENING IN THE BOWEL WAS NOTED AND WAS DRAINING INTO A POCKET. A BOWEL RESECTION WAS PERFORMED, REMOVING 1 1/2 FEET OF BOWEL AND TWO ENTEROTOMIES WERE MADE. THE ENTEROTOMIES WERE REPAIRED AND A NON-BARD VICRYL MESH WAS IMPLANTED. ON (B)(6) 2012- THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX FTL DAVOL INC. NA 43FD254

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| R WOUND VAC TREATMENT