BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 2801735 · Received October 12, 2012

    Report

    Report Number
    1213643-2012-00698
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    June 19, 2006
    Report Date
    March 26, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT HAS CO-MORBIDITIES INCLUDING OBESITY AND MULTIPLE ABDOMINAL SURGERIES. THE INFORMATION PROVIDED INDICATES THAT THE PATIENT DEVELOPED AND WAS TREATED FOR RECURRENCE, WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE IFU. A MANUFACTURING REVIEW WAS PERFORMED, AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. ADDITIONALLY, IT APPEARS THE MESH REMAINS PARTIALLY IMPLANTED, AND NO PRODUCT HAS BEEN RETURNED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED. SEE MDR 1213643-2007-00830 FOR INFORMATION RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2006.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: (B)(6) 2001 - PATIENT UNDERWENT REPAIR OF RECURRENT VENTRAL HERNIA WITH IMPLANT OF COMPOSIX MESH. THE FASCIA HAD MULTIPLE DEFECTS LIKE SWISS CHEESE. (B)(6) 2006 - PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA. LYSIS OF ADHESIONS WAS PERFORMED. THE PREVIOUSLY IMPLANTED COMPOSIX MESH WAS SPLIT LONGITUDINALLY. THE MESH HAD PULLED AWAY FROM THE FASCIA EDGES AND HAD HERNIAS AROUND THE EDGES OF THE MESH. ADDITIONAL WALL WAS NOTED TO BE VERY THIN. COMPOSIX KUGEL MESH WAS IMPLANTED, AND IT APPEARS THAT THE COMPOSIX MESH WAS PARTIALLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43BLD143

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention