BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 2232575 · Received August 24, 2011

    Report

    Report Number
    1213643-2011-00395
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2008
    Report Date
    October 2, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K971745
    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 RAE (B)(4). SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL 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 INCISIONAL HERNIA REPAIR WITH COMPOSIX MESH ON (B)(6) 2003. FOLLOWING THE REPAIR THE PATIENT WAS SEEN IN MULTIPLE OFFICE VISITS WITH COMPLAINTS OF PAIN. FIVER YEARS POST IMPLANT THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. AN ABSCESS CAVITY AND FISTULA WAS IDENTIFIED. AFTER LYSIS OF ADHESIONS WERE PERFORMED THE COMPOSIX MESH WAS PARTIALLY EXCISED. FOUR DAYS LATER THE PATIENT UNDERWENT ANOTHER EXPLORATORY LAPAROTOMY WHERE THE REMAINING COMPOSIX MESH WAS EXCISED. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT HAS A COMPLEX HISTORY OF ABDOMINAL REPAIRS INCLUDING A SIGMOID RELEASE IN 2002. THE MEDICAL RECORDS INDICATE THE PATIENT DEVELOPED AND WAS TREATED FOR AN ABSCESS, FISTULA AND ADHESIONS, ALL OF WHICH ARE KNOWN ADVERSE EVENTS LISTED IN THE IFU. 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) 2003 - PATIENT UNDERWENT REPAIR OF INCISIONAL HERNIA WITH COMPOSIX MESH. ON (B)(6) 2003 - OFFICE VISIT, PATIENT DOING WELL SINCE SURGERY. ON (B)(6) 2004 - OFFICE VISIT, PATIENT COMPLAINS OF ABDOMINAL PAIN, NO DRAINAGE OR ABSCESS. ON (B)(6) 2006 - OFFICE VISIT, PATIENT COMPLAINS OF INTERMITTENT ABDOMINAL PAIN, GAS AND IRREGULAR BOWEL MOVEMENT. ON (B)(6) 2007 - OFFICE VISIT, LEFT UPPER QUADRANT PAIN. ON (B)(6) 2008 - OFFICE VISIT, PATIENT COMPLAINS OF LOWER QUADRANT ABDOMINAL PAIN. ON (B)(6) 2008 - PATIENT UNDERWENT EXPLORATORY LAPAROTOMY. AN ABSCESS CAVITY AND FISTULA WERE IDENTIFIED. AFTER ADHESIOLYSIS WERE PERFORMED THE COMPOSIX MESH WAS PARTIALLY EXCISED. ON (B)(6) 2008 - PATIENT UNDERWENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, RESECTION OF ABDOMINAL WALL AND REMOVAL OF COMPOSIX MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC NA 43FMD236

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention