BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1918397 · Received December 2, 2010

    Report

    Report Number
    1213643-2010-00530
    Event Type
    Injury
    Date Received
    December 2, 2010
    Report Date
    November 4, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADD'L INFO AND THE DEVICE REMAINS IMPLANTED THEREFORE, AN EVAL CANNOT BE COMPLETED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS REC'D AND REVIEWED TO DATE. A REVIEW OF MFG DOCUMENTATION DID NOT PROVIDE ANY EVIDENCE OF A MFG RELATED CAUSE FOR THE REPORTED EVENTS. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS OR CAN BE RETURNED. 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 (REFERENCE MEDWATCH 1213642-2010-00531). ON (B)(6) 2006 - BARD COMPOSIX KUGEL HERNIA PATCH ((B)(4)) 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 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD208

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other