BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2120402 · Received June 3, 2011

    Report

    Report Number
    1213643-2011-00258
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 8, 2008
    Report Date
    January 13, 2010
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    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 ADD'L EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE WE ARE SUBMITTING THIS MDR BASED ON THE ADD'L INFO RECEIVED. BASED ON THE MEDICAL RECORD REVIEW, THE PT UNDERWENT VENTRAL HERNIA REPAIR WITH COMPOSIX KUGEL ON (B)(6) 2005. LYSIS OF ADHESIONS WAS PERFORMED. APPROX THREE YEARS POST IMPLANT, THE PT UNDERWENT REPAIR OF A RECURRENT INCISIONAL HERNIA WITH A NON-BARD MESH. THE PREVIOUSLY PLACED COMPOSIX KUGEL MESH WAS IDENTIFIED AND NOTED TO BE IN PLACE. THE NON-BARD MESH WAS SUTURED MESH TO MESH FOR A STRONG HOLDING REPAIR. ON (B)(6) 2009, THE PT UNDERWENT PRIMARY REPAIR WITH A NON-BARD ONLAY, AND MESH. ON (B)(6) 2009, THE PT UNDERWENT REPAIR OF A VENTRAL INCISIONAL HERNIA WITH NO MESH. THE MEDICAL RECORDS NOTE THE DEFECT WAS BELOW THE PREVIOUSLY REPAIRED DEFECT. THE MEDICAL RECORDS PROVIDED DO NOT INDICATE A DEVICE RELATED FAILURE AS CAUSING OR CONTRIBUTING TO THE REPORTED EVENT. ADDITIONALLY, THE COMPOSIX KUGEL MESH REMAINS IMPLANTED.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2005, PT UNDERWENT REPAIR OF VENTRAL HERNIA WITH COMPOSIX KUGEL. ADHESIOLYSIS WAS PERFORMED. A COUPLE DEFECTS WERE IDENTIFIED AND BRIDGED BY FASCIAL GAPS. ON (B)(6) 2008, PT UNDERWENT REPAIR OF RECURRENT LARGE INCISIONAL HERNIA WITH NON-BARD MESH. THE NON-BARD MESH WAS SUTURED TOGETHER WITH THE PREVIOUSLY PLACED COMPOSIX KUGEL. ON (B)(6) 2009, PT UNDERWENT PRIMARY REPAIR WITH NON-BARD ONLAY MESH. ON (B)(6) 2009, PT UNDERWENT REPAIR OF VENTRAL INCISIONAL HERNIA WITH NO MESH INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC. NA 43APD255

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention