BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2021335 · Received March 8, 2011

    Report

    Report Number
    1213643-2011-00069
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR AN INFECTION SIX YEARS AFTER IMPLANTATION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT BASED ON THE INFO CURRENTLY AVAILABLE. FURTHERMORE, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2011-00065, MDR 1213643-2011-00066, MDR 1213643-2011-00067 AND MDR 1213643-2011-00068 FOR INFO RELATED TO THE FOUR COMPOSIX E/X MESHES IMPLANTED ON (B)(6) 2003. SEE MDR 1213643-2011-00070 FOR INFO RELATED TO THE OTHER NON-RECALLED COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2003. INFO RELATED TO THE RECALLED COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2003 WILL BE REPORTED IN ACCORDANCE (B)(4).

    Description of Event or Problem · 1

    ATTORNEY REPORTED: (B)(6) 2003: PT UNDERWENT AN INCISIONAL HERNIA REPAIR AND HAD SEVEN BARD MESHES IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2009: PT WAS INFORMED THAT THESE MESHES HAD TO BE REMOVED DUE TO AN (B)(6) INFECTION AND SEROSAL INJURIES. ON (B)(6) 2010: PROCEDURE CARRIED OUT AND MULTIPLE PRODUCT FAILURES WERE DESCRIBED. THE PT SUFFERED INJURIES AS A RESULT OF THESE FAILURES. THE PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DND387

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention