BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2317067 · Received October 28, 2011

    Report

    Report Number
    1213643-2011-00587
    Event Type
    Death
    Date Received
    October 28, 2011
    Date of Event
    December 19, 2007
    Report Date
    October 5, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NI
    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. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY REPORT INDICATES THAT THE PATIENT SUSTAINED SERIOUS AND PERMANENT INJURIES AS A RESULT OF THE COMPOSIX KUGEL MESH USED IN THE PATIENT'S HERNIA REPAIR. THE REPORT DOES NOT IDENTIFY A SPECIFIC DEVICE PROBLEM AND NO PRODUCT WAS RETURNED FOR EVALUATION. ADDITIONALLY, MEDICAL RECORDS, AUTOPSY REPORT OR ANY OTHER MEDICAL INFORMATION HAS NOT BEEN 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: NI/NI/NI - PATIENT UNDERWENT HERNIA REPAIR WITH COMPOSIX KUGEL. ON (B)(6) 2007 - THE PATIENT EXPIRED. THE ATTORNEY ALLEGES THE PATIENT SUSTAINED SERIOUS AND PERMANENT INJURIES, SUFFERING PAIN, AND DEATH AS A RESULT OF THE COMPOSIX KUGEL MESH.

    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 Death