BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1933815 · Received December 14, 2010

    Report

    Report Number
    1213643-2010-00551
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    July 15, 2008
    Report Date
    November 18, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. ALTHOUGH NO SAMPLE WAS REC'D, HOWEVER, THE EVENT INFO PROVIDED INDICATES THAT THE PT DEVELOPED AND WAS TREATED FOR AN ABDOMINAL WALL ABSCESS AND WOUND INFECTION. WHILE INFECTION IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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." A MFG RECORD REVIEW INCLUDING STERILITY HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE, AND THERE WAS NO EVIDENCE OF A MFG RELATED CAUSE FOR THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY AN ATTORNEY FOR THE PT: ON 07/NI/2006--PT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. PT'S HERNIA WAS REPAIRED WITH A LARGE OVAL BARD COMPOSIX KUGEL MESH (B)(4). ON (B)(6) 2006--PT WAS ADMITTED TO HOSPITAL FOR REMOVAL OF INFECTED MESH. ON EXAM, SHE WAS FOUND TO HAVE AN ABSCESS POCKET ON THE UNDERSIDE OF THE MESH. PT UNDERWENT PARTIAL EXCISION OF MESH THAT WAS IMPLANTED IN (B)(6) 2006. ON (B)(6) 2007--AN ADD'L BARD COMPOSIX KUGEL MESH WAS INSERTED WHEN SHE PRESENTED TO THE HOSPITAL WITH ADD'L ABDOMINAL PAINS. SHE WAS DISCHARGED 3 DAYS LATER. PT HAD MULTIPLE ADMISSIONS DUE TO INFECTIONS AND DRAINAGE OF THE WOUND IN 2007 AND 2008. ON (B)(6) 2008--PT WAS ADMITTED TO THE HOSPITAL DUE TO INFECTION. SURGEON PERFORMED A PROCEDURE AND FOUND POCKETS OF PUS ON THE DOWNSIDE OF THE MESH AND TRACKED THE INFECTION TO UPPER PIECES OF MESH. SURGEON REMOVED ALL PREVIOUS IMPLANTED MESH AND CLOSED THE AREA WITHOUT THE USE OF ADD'L MESH. PT WAS DISCHARGED ALMOST A WEEK AFTER BEING ADMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURF1549

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention