BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1914908 · Received November 30, 2010

    Report

    Report Number
    1213643-2010-00513
    Event Type
    Death
    Date Received
    November 30, 2010
    Date of Event
    August 29, 2008
    Report Date
    November 1, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED AND REQUESTS FOR ADDITIONAL INFORMATION HAVE NOT BEEN RESPONDED TO. THIS MDR CONTAINS ALL PT AND DEVICE RELATED INFORMATION DAVOL HAS RECEIVED TO DATE AND NO CONCLUSION CAN BE DRAWN AT THIS TIME. ADDITIONAL INFORMATION INCLUDING PT INFORMATION, COPIES OF MEDICAL INFORMATION/RECORDS AND DEATH CERTIFICATE/AUTOPSY REPORT HAVE BEEN REQUESTED. A DHR AND MANUFACTURING RECORD REVIEW HAS NOT BEEN CONDUCTED, SINCE NO SPECIFIC PRODUCT CODE OR LOT NUMBER WERE PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE ATTORNEY PER LEGAL SUMMONS. ON (B)(6) 2008, PATIENT UNDERWENT A VENTRAL HERNIA REPAIR. HIS MEDICAL RECORDS (NOT PROVIDED) INDICATE THAT A COMPOSIX E/X MESH WAS IMPLANTED IN THIS PROCEDURE. ON (B)(6) 2008, THE PT HAD HIS MESH REMOVED BECAUSE IT BECAME INFECTED AND CAUSED NECROTIZING FASCIITIS OF THE ABDOMINAL WALL. THE INJURIES HE SUFFERED ARE RECOUNTED IN HIS MEDICAL RECORDS (NOT PROVIDED). ON (B)(6) 2008, PT DIED AS A RESULT OF NECROTIZING FASCIITIS OF THE ABDOMINAL WALL AND FOURNIER GANGRENE OF THE GENITALIA AND SUBSEQUENT SEPTIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death