BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2233943 · Received August 30, 2011

    Report

    Report Number
    1213643-2011-00406
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    July 8, 2008
    Report Date
    November 6, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    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 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. BASED ON THE MEDICAL RECORD REVIEW, THE PT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL ON (B)(6) 2008. FOLLOWING THE PROCEDURE, THE PT HAD MULTIPLE OFFICE VISITS WITH COMPLAINTS OF PAIN AND INCISIONAL DRAINAGE. THE PT UNDERWENT INCISION AND DRAINAGE OF AN ABDOMINAL WALL ABSCESS ON (B)(6) 2008, AND CULTURES REVEALED NO PRESENCE OF INFECTION. ALTHOUGH THERE IS NO INDICATION THE MESH WAS THE CAUSE, ON (B)(6) 2008, THE PT TESTED POSITIVE FOR GROWTH OF AN INFECTION. SUBSEQUENTLY, THE PT UNDERWENT EXCISION OF COMPOSIX KUGEL ON (B)(6) 2008. BASED ON THE INFO PROVIDED, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR INFECTION. THE WARNING SECTION OF THE IFU STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    BASED ON THE MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2008, PT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR WITH COMPOSIX KUGEL. ON (B)(6) 2008, OFFICE VISIT, PT COMPLAINTS OF PAIN. INCISION HEALING WELL, SMALL AMOUNT OF FLUID DRAINING. ON (B)(6) 2008, OFFICE VISIT, DRAINING SEROMA, POSSIBLE INFECTION. ON (B)(6) 2008, PT UNDERWENT INCISION AND DRAINAGE OF SEROMA. ON (B)(6) 2008, OFFICE VISIT, HEALING QUICKLY, NO VISABLE SUTURES. (B)(6) 2008, OFFICE VISIT, WOUND LOOKS GOOD. ON (B)(6) 2008, OFFICE VISIT, MODERATE DRAINAGE. (B)(6) 2008, OFFICE VISIT, (B)(6), ANTIBIOTICS PRESCRIBED. (B)(6) 2008, OFFICE VISIT, PT HAS SMALL TO MODERATE DRAINAGE FROM UNDERNEATH THE WOUND. ON (B)(6) 2008, PT UNDERWENT EXPLORATION OF ABDOMINAL WALL ABSCESS. (B)(6) 2008, PT UNDERWENT EXCISION OF COMPOSIX KUGEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA 43LQD184

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention