BEUDAMED
    FDA Adverse Event Other Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2358209 · Received November 30, 2011

    Report

    Report Number
    1213643-2011-00691
    Event Type
    Other
    Date Received
    November 30, 2011
    Date of Event
    January 13, 2009
    Report Date
    January 8, 2010
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. IT WAS REPORTED THAT THE PT EXPERIENCE PAIN AFTER IMPLANT OF THE COMPOSIX KUGEL MESH. A DIAGNOSTIC LAPAROSCOPY IN (B)(6) 2006, DID NOT REVEAL ANY PROBLEMS WITH THE MESH. IN 2009, CT SCAN WAS PERFORMED AND DID NOT FIND ANY DEFECTS. IT WAS NOTED THAT THE MESH WAS IN AN "UNUSUAL LOCATION" AND WAS SUBSEQUENTLY REMOVED. WE HAV CONTACTED THE INITIAL REPORTER TO OBTAIN ADD'L INFO AND TO HAVE THE EXPLANTED MESH RETURNED FOR EVAL. WITH NO SAMPLE RETURNED AND NO LOT NUMBER PROVIDED, FURTHER EVAL OF THE DEVICE AND MFG RECORDS IS NOT POSSIBLE. WITH THE INFO PROVIDED, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY. ON (B)(6) 2004, REPAIR OF A RIGHT VENTRAL HERNIA WITH A COMPOSIX KUGEL MESH. ON (B)(6) 2005, MULTIPLE TRIGGER POINT INJECTIONS IN DIFFERENT GROUP OF MUSCLES ABDOMINAL SCAR AREA X3. ON (B)(6) 2006, DIAGNOSTIC LAPAROSCOPY. "THE PREVIOUS HERNIA REPAIR DID NOT APPEAR TO HAVE ANY ADHESION BEHIND IT NOR ANY PROBLEMS WITH THE MESH ERODING THROUGH." ON (B)(6) 2009, REMOVAL OF MESH IN THE RIGHT ABDOMINAL WALL AND REPAIR OF ACQUIRED ABDOMINAL WALL DEFECT WITH NON-BARD GRAFT. MESH WAS NOTED TO BE UNDER AND ABUTTING THE ASIS.

    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 53 YR Required Intervention