BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1918365 · Received December 2, 2010

    Report

    Report Number
    1213643-2010-00531
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    January 1, 2006
    Report Date
    November 4, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADD'L INFO AND TO REQUEST THE DEVICE, THEREFORE, AN EVAL CANNOT BE COMPLETED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D AND REVIEWED TO DATE. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AN INFECTION. 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." AS THE MESH WAS IMPLANTED, A YEAR OR MORE BEFORE THE INFECTION DEVELOPED/WAS DIAGNOSED, THE MESH MOST LIKELY DID NOT CAUSE THE INFECTION. THERE WAS NO PRODUCT SPECIFIC FAILURE MODE ALLEGED AND NO PRODUCT HAS BEEN RETURNED FOR EVAL, THEREFORE, A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2005 - BARD KUGEL PATCH WAS IMPLANTED TO REPAIR A HERNIA. ON NI/NI/NI - THE PT PRESENTED WITH FISTULA AND INFECTION. ON (B)(6) 2006 - THE PATCH WAS EXPLANTED. ON (B)(6) 2006 - BARD COMPOSIX KUGEL HERNIA PATCH (REFERENCE MEDWATCH 1213642-2010-00530) WAS IMPLANTED AT WHICH POINT THE PT STATES HE IS EXPERIENCING ADHESIONS OF THE SMALL INTESTINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention