BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2232574 · Received August 24, 2011

    Report

    Report Number
    1213643-2011-00394
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    February 23, 2007
    Report Date
    December 14, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 RAE (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 RECORDS REVIEW THE PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH KUGEL PATCH ON (B)(6) 2006. DURING THE REPAIR THE LYSIS OF ADHESIONS WERE PERFORMED. APPROXIMATELY ONE YEAR POST IMPLANT THE PATIENT UNDERWENT REPAIR OF A RECURRENT HERNIA WITH COMPOSIX E/X. THE MEDICAL RECORDS NOTE THE KUGEL PATCH APPEARED TO BE SOMEWHAT FOLDED, ALTHOUGH THERE IS NO INDICATION OF THE CAUSE. LYSIS OF ADHESIONS WERE PERFORMED AND THE KUGEL PATCH WAS EXCISED. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MEDICAL RECORDS INDICATE THE PATIENT DEVELOPED AND WAS TREATED FOR RECURRENCE AND ADHESIONS, BOTH OF WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. A LOT NUMBER HAS NOT BEEN PROVIDED SO THEREFORE A MANUFACTURING REVIEW CANNOT BE PERFORMED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2002 - PATIENT UNDERWENT UMBILICAL HERNIA REPAIR WITH A NON-BARD MESH. ON (B)(6) 2006 - PATIENT UNDERWENT VENTRAL HERNIAL REPAIR WITH KUGEL PATCH POST OPEN CHOLECYSTECTOMY. LYSIS OF ADHESIONS WERE PERFORMED. A SMALL FLUID COLLECTION WAS IDENTIFIED IN THE SUBCUTANEOUS TISSUE. ON (B)(6) 2007 - PATIENT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR WITH COMPOSIX E/X. LYSIS OF ADHESIONS AND EXCISION OF KUGEL PATCH WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention