BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2232577 · Received August 24, 2011

    Report

    Report Number
    1213643-2011-00397
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    November 10, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS ORIGINALLY REPORTED TO DAVOL AS A RECALLED COMPOSIX KUGEL MESH; THEREFORE, DAVOL ORIGINALLY REPORTED THIS EVENT TO THE FDA IN ACCORDANCE WITH (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFORMATION INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFORMATION RECEIVED. BASED ON THE MEDICAL RECORD REVIEW THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA WITH COMPOSIX KUGEL ON (B)(6) 2006. AN OFFICE VISIT ON (B)(6) 2006 STATES A SMALL RECURRENT HERNIA WAS PRESENT OVER THE MID PART OF THE PREVIOUS INCISION. THE MEDICAL RECORDS NOTE THE PATIENT UNDERWENT REPAIR OF THE RECURRENT HERNIA ON (B)(6) 2007 WITH A NON-BARD MESH. THE OPERATIVE REPORT DOES NOT IDENTIFY THE PRESENCE OF A COMPOSIX KUGEL NOR ANY INDICATION THAT THE MESH WAS EXPLANTED OR DISRUPTED. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WHILE THE PATIENT WAS TREATED FOR A RECURRENCE THERE IS NO INDICATION A DEVICE FAILURE OF THE COMPOSIX KUGEL MESH WAS THE CAUSE OF THE RECURRENCE. ADDITIONALLY, RECURRENCE IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE THAT THE MESH WAS EXPLANTED. BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION A DEVICE FAILURE OCCURRED.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2006 - PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH COMPOSIX KUGEL. ON (B)(6) 2006 - OFFICE VISIT, MINIMAL SWELLING AROUND THE UPPER PORTION OF INCISION, NO SIGN OF INFECTION. ON (B)(6) 2006 - OFFICE VISIT, NO SWELLING OR DRAINAGE, STAPLES REMOVED. ON (B)(6) 2006 - OFFICE VISIT, SMALL RECURRENT HERNIA AT MID PART OF INCISION. ON (B)(6) 2007 - PATIENT UNDERWENT REPAIR OF RECURRENT HERNIA WITH NON-BARD MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43DOD270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention