BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1591853 · Received January 27, 2010

    Report

    Report Number
    1213643-2010-00034
    Event Type
    Death
    Date Received
    January 27, 2010
    Date of Event
    January 2, 2008
    Report Date
    December 30, 2009
    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
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THE ADDITIONAL INFO REQUESTED INCLUDES PT INFO, COPIES OF MEDICAL INFO/RECORDS AND DEATH CERTIFICATE/AUTOPSY REPORT. THIS MDR INCLUDES ALL; PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B) (6) 2007 - THE PT UNDERWENT A HERNIA REPAIR WITH A BARD COMPOSIX E/X MESH ELLIPTICAL 10.0" X 14.0", PRODUCT CODE 0123113, LOT NUMBER HURB3197. ON (B) (6) 2008 - THE DEFECTIVE PATCH CAUSED AND CONTRIBUTED TO THE DEATH OF THE PT ON (B) (6) 2008. THE COMPOSIX E/X MESH WAS DEFECTIVE BECAUSE [IT] FAILED TO PERFORM SAFELY AND EFFECTIVELY FOR THE PURPOSE ORIGINALLY DESIGNED. PT'S COMPOSIX E/X MESH FAILED WHILE IN HER BODY, CAUSING HER TO DEVELOP SERIOUS AND PAINFUL PHYSICAL COMPLICATIONS, AND EVENTUALLY CAUSED DEATH.

    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 HURB3197

    Patients

    Seq Age Sex Outcome Treatment
    1 Death