BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1973864 · Received January 19, 2011

    Report

    Report Number
    1213643-2011-00016
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    January 4, 2010
    Report Date
    April 9, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    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 2008004. SUBSEQUENTLY, DAVOL HAS RECEIVED ADDITIONAL EVENT INFO INDICATING THAT THE ASSOCIATED EVENT DEVICE IS NOT A RECALLED COMPOSIX KUGEL MESH; THEREFORE, WE ARE SUBMITTING THIS MDR BASED ON THE ADDITIONAL INFO RECEIVED. THE MEDICAL RECORDS PROVIDED INDICATE THE PT DEVELOPED AND WAS TREATED FOR AN INFECTION/ABSCESS ALMOST ONE YEAR POST-IMPLANT OF THE BARD COMPOSIX MESH IMPLANTED IN (B)(6) 2008. 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." THE SURGEON'S IMPRESSION INDICATES "INFECTION IS MORE LIKELY RELATED TO SMALL BOWEL FISTULA BUT, BY HISTORY, IS POSSIBLE THE PT MAY HAVE HAD TRAUMA TO THE ABDOMINAL WALL CARRYING WOOD AND MAY HAVE SKIN ORGANISMS AS A SOURCE OF INFECTION." IT IS UNCLEAR WHETHER ONE OR BOTH MESHES WERE EXPLANTED, HOWEVER, THE TWO MESHES HAD BEEN TACKED TOGETHER AND BASED ON THE EXPLANT OPERATIVE REPORT, THE SURGEON "FELT AROUND THE PERIMETER OF THE FASCIA AND I DID NOT FEEL ANY PIECES OF OLD MESH AT ALL". THE MEDICAL RECORDS PROVIDED DO NOT OTHERWISE SPECIFY A SPECIFIC PRODUCT PROBLEM AND NO PRODUCT WAS RETURNED FOR EVAL, THEREFORE, BASED ON THE CURRENTLY AVAILABLE INFO, THERE IS NO INDICATION THAT A FAILURE IN THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. SEE MDR 1213643-2010-00216 FOR INFO RELATED TO THE BARD COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2008.

    Description of Event or Problem · 1

    INFO FROM MEDICAL RECORDS RECEIVED FOR REVIEW: ON (B)(6) 2006 - REDUCTION AND REPAIR OF INCARCERATED INCISIONAL (SUPRA-UMBILICAL AREA) W/BARD COMPOSIX KUGEL MESH. ON (B)(6) 2006 - EVACUATION OF POSTOPERATIVE LARGE ABDOMINAL WALL HEMATOMA W/DEBRIDEMENT AND CLOSURE OF WOUND. ON (B)(6) 2008 - REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA WITH BARD COMPOSIX MESH OVER PREVIOUSLY PLACED MESH. PER OPERATIVE REPORT, THE COMPOSIX MESH WAS "FASHIONED AND PLACED INTRA-ABDOMINALLY AND TACKED TO THE SURROUNDING TISSUE AND OLD MESH". ON (B)(6) 2009 - INCISION AND DRAINAGE OF ABDOMINAL WALL INFECTION W/DRAIN PLACEMENT. TWO ABSCESS POCKETS IDENTIFIED. NO EVIDENCE OF SMALL BOWEL FISTULA. TREATED W/IV ANTIBIOTICS. WOUND VAC THERAPY ATTEMPTED BUT REFUSED DUE TO DISCOMFORT. ON (B)(6) 2010 - EXCISION OF INFECTED ABDOMINAL WALL, RESECTION OF ABDOMINAL WALL INFECTED MESH, PLACEMENT OF ALLODERM, SMALL BOWEL RESECTION. MESH WAS NOTED TO HAVE SOMEWHAT ERODED INTO SMALL BOWEL. TREATED W/ANTIBIOTICS, WOUND VAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43APD253

    Patients

    Seq Age Sex Outcome Treatment
    1