BEUDAMED
    FDA Adverse Event Death Summary report: N

    MESH - COMPOSIX

    MDR report key: 1723876 · Received June 9, 2010

    Report

    Report Number
    1213643-2010-00268
    Event Type
    Death
    Date Received
    June 9, 2010
    Report Date
    May 13, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    KK971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: PATIENT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH HER USE OF DEFECTIVE PRODUCT, THE BARD COMPOSIX MESH. SPECIFICALLY, AS A RESULT OF HAVING THE COMPOSIX MESH PATCH IMPLANTED IN PATIENT, PATIENT SUFFERED DISABLING PAIN, REQUIRED SURGICAL INTERVENTION AND DIED AS A RESULT OF COMPLICATIONS CAUSED BY THE COMPOSIX MESH PATCH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R