BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1723875 · Received June 9, 2010

    Report

    Report Number
    1213643-2010-00267
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    May 12, 2007
    Report Date
    May 12, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0760-06 OR Z-0761-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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. ADDITIONAL INFORMATION INCLUDING PATIENT INFORMATION, COPIES OF MEDICAL INFORMATION/RECORDS AND DEATH CERTIFICATE/AUTOPSY REPORT HAVE BEEN REQUESTED. A DHR REVIEW HAS NOT BEEN CONDUCTED, SINCE NO SPECIFIC PRODUCT CODE OR LOT NUMBER HAVE BEEN PROVIDED. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED OR REQUEST FOR ADDITIONAL INFORMATION HAS NOT BEEN RESPONDED TO. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORT: ON (B) (6) 2006, PATIENT HAD A LARGE COMPOSIX KUGEL MESH IMPLANTED TO REPAIR A HERNIA DEFECT. ON (B) (6) 2007, PATIENT SUFFERED INJURIES SUSTAINED BY AN INFECTED KUGEL PATCH. ON (B) (6) 2007, PATIENT FAILED TO RECOVER FROM THOSE INJURIES AND DIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death