BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 3070761 · Received April 15, 2013

    Report

    Report Number
    1213643-2013-00151
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    March 21, 2007
    Report Date
    March 21, 2013
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSION CAN BE DRAWN. THE PT WAS IMPLANTED WITH TWO COMPOSIX KUGEL MESHES IN 2004. IN 2007, THE PT UNDERWENT REMOVAL OF ONE, IT APPEARS TO BE THE RECALLED COMPOSIX KUGEL, NOT THE MESH BEING REPORTED IN THIS FILE. THE PT WAS TREATED FOR ADHESIONS WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. A REVIEW OF THE MFG RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE OF A MFG RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, IT APPEARS THE MESH REMAINS IMPLANTED. INFO RELATED TO THE RECALLED COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2004 WILL BE REPORTED IN ACCORDANCE WITH (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE PT'S ATTORNEY: ON (B)(6) 2004 - PT UNDERWENT REPAIR OF 4 INCISIONAL HERNIA'S, TWO COMPOSIX KUGEL MESHES WERE PLACED. ON (B)(6) 2007 - PT UNDERWENT LAPAROSCOPIC ADHESIOLYSIS AND EXCISION OF COMPOSIX KUGEL MESH. THE MESH WAS NOTED TO BE INTACT BUT WAS WRINKLED AND DID HAVE AN AREA OF A V POKING INTO THE ABDOMEN BUT NO FRACTURE OF THE RING. NO DAMAGE TO THE BOWEL. ON (B)(6) 2012 - LETTER FROM MD: "I WAS THE DOCTOR IN THE ABOVE REFERENCED SURGERY, IT IS IN MY OPINION TO A REASONABLE DEGREE OF MEDICAL PROBABILITY THAT THE MEMORY RECOIL RING IN THE BARD COMPOSIX KUGEL PATCH WAS NOT BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162021 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43FOD303

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention