BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2233944 · Received August 30, 2011

    Report

    Report Number
    1213643-2011-00407
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    December 27, 2007
    Report Date
    February 1, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIALLY THE ATTORNEY REPORTED THAT A SINGLE EVENT OF THE IMPLANT OF A COMPOSIX KUGEL MESH OCCURRED, HOWEVER, MEDICAL RECORDS WERE RECEIVED AND A REVIEW OF THESE RECORDS IDENTIFIED ANOTHER EVENT. BASED ON THE MEDICAL RECORD REVIEW THE PT UNDERWENT INCISIONAL VENTRAL HERNIA REPAIR WITH COMPOSIX KUGEL ON (B)(6) 2006. APPROX NINE MONTHS POST IMPLANT, THE PT DEVELOPED A RECURRENT HERNIA AND UNDERWENT REPAIR USING A SECOND COMPOSIX KUGEL. LYSIS OF ADHESIONS WERE PERFORMED DURING THE REPAIR. ON (B)(6) 2007, THE PT UNDERWENT REPAIR OF A RECURRENT HERNIA WITH A NON-BARD MESH. THE MEDICAL RECORDS NOTE THE COMPOSIX KUGEL MESHES WERE WRAPPED IN A BALL AND WERE BOTH EXCISED. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT REPORTEDLY DEVELOPED A RECURRENCE WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. THE PT ALSO DEVELOPED AND WAS TREATED FOR ADHESIONS, WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVAL AND NO PRODUCT IDENTIFIERS HAVE BEEN PROVIDED. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR 1213643-2008-00464 FOR INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2006.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2006, PT UNDERWENT INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL. ON (B)(6) 2006, PT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL. LYSIS OF ADHESIONS WERE PERFORMED. ON (B)(6) 2007, PT UNDERWENT RECURRENT INCISIONAL HERNIA REPAIR WITH A NON-BARD MESH. EXCISION OF COMPOSIX KUGEL PATCHES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention