BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2354883 · Received November 23, 2011

    Report

    Report Number
    1213643-2011-00678
    Event Type
    Death
    Date Received
    November 23, 2011
    Date of Event
    October 25, 2010
    Report Date
    November 2, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY ALLEGES FOLLOWING THE IMPLANT OF THE COMPOSIX KUGEL THE PATIENT EXPERIENCED A CHRONIC INFECTION ACCOMPANIED BY ABDOMINAL WALL ABSCESSES, FLUID COLLECTION, AND OPEN DRAINAGE. LESS THAN A YEAR FOLLOWING THE SURGERY THE PATIENT UNDERWENT MULTIPLE PROCEDURES WHERE PORTIONS OF THE COMPOSIX KUGEL MESH WERE EXCISED. THE PATIENT DEVELOPED SEPSIS AND EXPIRED ON (B)(6) 2010. THE ATTORNEY ALLEGES THE PATIENT 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 RESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." THE ATTORNEY ALSO STATES THE COMPOSIX KUGEL MESH WAS EXCISED IN PORTIONS, THE WARNING SECTION OF THE IFU STATES "DO NOT CUT OR RESHAPE THE BARD COMPOSIX KUGEL HERNIA PATCH, AS THIS COULD AFFECT ITS EFFECTIVENESS. CARE SHOULD BE TAKEN NOT TO CUT OR NICK THE PET RECOIL RING." ADDITIONALLY, NO LOT NUMBER, MEDICAL RECORDS OR A SAMPLE WAS PROVIDED. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: ON (B)(6) 2008 - THE PATIENT UNDERWENT REPAIR OF A VENTRAL HERNIA WITH COMPOSIX KUGEL. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INFECTION ACCOMPANIED BY ABDOMINAL WALL ABSCESSES, FLUID COLLECTION, AND OPEN DRAINAGE. LESS THAN A YEAR FOLLOWING THE SURGERY THE PATIENT UNDERWENT MULTIPLE PROCEDURES WHERE PORTIONS OF THE COMPOSIX KUGEL MESH WERE EXCISED. ON (B)(6) 2010 - THE PATIENT EXPIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death| R