BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1973862 · Received January 19, 2011

    Report

    Report Number
    1213643-2011-00014
    Event Type
    Injury
    Date Received
    January 19, 2011
    Report Date
    April 28, 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
    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 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 HAS HAD APPROX 8 HERNIA SURGERIES. THERE IS NO INDICATION, HOWEVER, WITHIN THE MEDICAL RECORDS PROVIDED OF A SPECIFIC PRODUCT PROBLEM WITH THE MESH IMPLANTED ON (B)(6) 2006, THEREFORE, BASED ON THE CURRENTLY AVAILABLE INFO, THERE IS NO INDICATION THAT A FAILURE IN THIS DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. SEE MDR 1213643-2011-00015 FOR INFO RELATED TO THE BARD COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2007.

    Description of Event or Problem · 1

    INFO FROM MEDICAL RECORDS RECEIVED FOR REVIEW: ON (B)(6) 2006 - EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, REPAIR OF VENTRAL HERNIA W/BARD COMPOSIX KUGEL MESH. ON (B)(6) 2007 - SMALL BOWEL OBSTRUCTION, REPAIR OF VENTRAL HERNIA W/BARD COMPOSIX KUGEL MESH. THIS HERNIA WAS ABOVE THE HERNIA THAT WAS REPAIRED IN MAY 2006. ON (B)(6) 2009 - DRAINAGE OF ABSCESS. MASS WAS IN RIGHT LOWER QUADRANT WITH SUBCUTANEOUS ABSCESS. WOUND WAS PACKED WITH WET-DRY DRESSING. ON (B)(6) 2010 - EXPLANT OF INFECTED MESH. FISTULA NOTED AT RIGHT PERIUMBILICAL AREA. BARD COMPOSIX KUGEL MESH WAS ENTIRELY REMOVED. THERE WAS ANOTHER MARLEX PATCH IN THE AREA WHICH WAS REMOVED AS MUCH AS POSSIBLE. PT WAS FOUND TO HAVE AN ENTERIC FISTULA BENEATH THE PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43GND184

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention