BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2134809 · Received June 14, 2011

    Report

    Report Number
    1213643-2011-00278
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION REPORTED TO DAVOL, THE PATIENT HAD A COMPOSIX KUGEL MESH IMPLANTED. IT WAS REPORTED THAT A SMALL AREA OF WOUND HAD DEHISCED CAUSING INFECTION IN A SMALL PORTION OF THE MESH. UNUSUAL GRANULATION TISSUE HAS FORMED IN THAT AREA AND REPORTEDLY SEEMED TO EXTEND THROUGH THE EPTFE CONNECTING TO THE OMENTUM. THE INFECTED AREA OF MESH WAS REMOVED ALONG WITH THE INTERNAL MEMORY RING, THE DEFECT WAS THEN SUTURED TOGETHER AND COLLAMEND FM WAS PLACED IN A RETRORECTUS POSITION TO BOLSTER THE REPAIR. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CONTRIBUTED TO THE ALLEGED EVENT. THE PATIENT WAS REPORTEDLY TREATED FOR INFECTION. WHILE NO OPERATIVE OR PATHOLOGY REPORTS HAVE BEEN RECEIVED THAT INDICATE THE MESH IS THE SOURCE OF THE REPORTED INFECTION, THE PRODUCT'S IFU DOES LIST IT AS A POSSIBLE ADVERSE REACTION. THE IFU STATES THAT IF AN INFECTION DEVELOPS, IT SHOULD BE TREATED AGGRESSIVELY. BASED ON THE INFORMATION RECEIVED, NO CONCLUSION CAN BE DRAWN. NO PRODUCT CODES OR DATE OF IMPLANT WERE PROVIDED, THEREFORE, WE ARE FILING THIS MDR UNDER THE 510(K) NUMBER K003323. IT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BASED ON INFORMATION REPORTED TO DAVOL: NI/NI/NI - PATIENT HAD A COMPOSIX KUGEL MESH IMPLANTED. ON (B)(6) 2011 - A SMALL AREA OF WOUND HAD DEHISCED CAUSING INFECTION IN A SMALL PORTION OF THE MESH. UNUSUAL GRANULATION TISSUE HAS FORMED IN THAT AREA AND SEEMED TO EXTEND THROUGH THE EPTFE CONNECTING TO THE OMENTUM. THE INFECTED AREA OF MESH WAS REMOVED ALONG WITH THE INTERNAL RECOIL RING, THE DEFECT WAS THEN SUTURED TOGETHER AND COLLAMEND FM WAS PLACED TO COMPLETE THE REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention