BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 2885102 · Received December 12, 2012

    Report

    Report Number
    1213643-2012-00862
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 14, 2012
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0760-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE DEVICE FOUND THE PATCH TO BE BENT OVER AND CURLED UP AROUND THE CIRCUMFERENCE OF THE PATCH. THERE WAS NO TISSUE ATTACHED TO THE EPTFE SIDE OF THE PATCH AND THE EPTFE HAD NUMEROUS WRINKLES IN IT. A VERY SMALL AMOUNT OF TISSUE ATTACHMENT/INGROWTH INTO THE MESH SIDE OF PATCH AND WAS DISTORTED IN MUCH THE SAME MANNER AS THE EPTFE SIDE OF THE PATCH. THE PATCH WAS VISUALLY AND MANUALLY INSPECTED, ALL COMPONENTS APPEARED TO BE INTACT. THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR 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." ADDITIONALLY, IT IS ALLEGED THE PATIENT DEVELOPED AN ABSCESS WHICH IS ALSO A KNOWN ADVERSE EVENT LISTED IN THE IFU. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. BASED ON THE VISUAL EXAMINATION AND THE INFORMATION PROVIDED, NO DEFINITIVE CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY: IT WAS ALLEGED ON (B)(6) 2005 THE PATIENT WAS IMPLANTED WITH A BARD COMPOSIX KUGEL PATCH FOR REPAIR OF A VENTRAL HERNIA. SEVEN YEARS LATER THE PATIENT DEVELOPED AN ABSCESS AND ON (B)(6) 2012 UNDERWENT EXPLANT OF THE "INFECTED CK PATCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX KUGEL FTL DAVOL INC NA 43DND375

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention