BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH- COMPOSIX KUGEL

    MDR report key: 2070915 · Received April 19, 2011

    Report

    Report Number
    1213643-2011-00169
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    August 23, 2004
    Report Date
    March 12, 2007
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    Z-0524-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REVIEW OF MEDICAL RECORDS, THE PATIENT UNDERWENT MULTIPLE INCISIONAL HERNIA REPAIRS USING A COMPOSIX KUGEL PATCH ON (B)(6) 2004. EXTENSIVE LYSIS OF ADHESIONS WERE PERFORMED AND MULTIPLE FASCIAL DEFECTS WERE NOTED. POSTOPERATIVELY, THE PATIENT DEVELOPED A SEROMA, WHICH WAS NOT DRAINED AND THE PATIENT WAS RELEASED. THE PATIENT THEN REPORTED PAIN APPROXIMATELY 3 MONTHS AFTER SURGERY AND A RECURRENT VENTRAL HERNIA WAS IDENTIFIED IN CT SCAN. ON (B)(6) 2004, THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR WITH A NON-BARD PRODUCT. THE NON-BARD PATCH WAS REAPPROXIMATED TO THE INFERIOR EDGE OF THE COMPOSIX KUGEL PATCH TO TREAT THE RECURRENCE. LYSIS OF SOME ADHESIONS WERE PERFORMED. BASED ON THE INFORMATION RECEIVED THERE IS NO INDICATION OF A DEVICE FAILURE. THE PATIENT DEVELOPED PAIN IN 2007 AS A RESULT OF CLIMBING AND STRETCHING WHILE ON A LADDER, WHICH OCCURRED 3 YEARS POST EXPLANT OF THE BARD MESH AND IMPLANT OF AN UNIDENTIFIED NON-BARD MESH. THE PATIENT WAS TREATED FOR RECURRENCE FOLLOWING THE COMPOSIX KUGEL MESH IMPLANT AND ALTHOUGH THERE IS NO INDICATION OF A DEVICE FAILURE CAUSING OR CONTRIBUTING TO THE RECURRENCE, IT SHOULD BE NOTED THAT RECURRENCE IS A KNOWN ADVERSE EVENT LISTED IN THE IFU.

    Description of Event or Problem · 1

    BASED ON THE REVIEW OF MEDICAL RECORDS PROVIDED BY THE PATIENT: (B)(6) 2004 - PATIENT UNDERWENT REPAIR OF MULTIPLE INCISIONAL HERNIAS WITH INSERTION OF BARD COMPOSIX KUGEL PATCH. EXTENSIVE LYSIS OF ADHESIONS WERE PERFORMED. POSTOPERATIVELY, THE PATIENT DEVELOPED A SEROMA, WHICH WAS NOT DRAINED. MULTIPLE FASCIA DEFECTS WERE NOTED. ON (B)(6) 2004 - PATIENT UNDERWENT RECURRENT HERNIA REPAIR WITH A NON-BARD PRODUCT. LYSIS OF ADHESIONS WERE PERFORMED. COMPOSIX KUGEL PATCH WAS IDENTIFIED WITH THE INFERIOR EDGE BEING DISSECTED FREE; THE SUPERIOR EDGE WAS LEFT INTACT. DURING THE SURGERY A NON- BARD SOFT TISSUE PATCH WAS REAPPROXIMATED TO THE INFERIOR EDGE OF THE COMPOSIX KUGEL PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH- COMPOSIX KUGEL FTL DAVOL INC. NA 43LND186

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention