BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 1932950 · Received December 15, 2010

    Report

    Report Number
    1213643-2010-00555
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    April 20, 2009
    Report Date
    November 1, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INFO PROVIDED BY THE ATTORNEY IN (B)(6) 2010 PROVIDED EVIDENCE OF ONE MESH EVENT AND SUGGESTED THAT THE PRODUCT WAS PART OF THE COMPOSIX KUGEL RECALL, THEREFORE, THE EVENT WAS INITIALLY REPORTED IN ACCORDANCE WITH RAE (B)(4). HOWEVER, THE REVIEW OF MEDICAL RECORDS PROVIDED IN (B)(6) 2010 INDICATES THAT THE PT DEVELOPED A RECURRENCE AND ALSO DEVELOPED AND WAS TREATED FOR AN INFECTION SIX YEARS AFTER IMPLANT OF A BARD FLAT MESH. 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." AS THE MESH WAS IMPLANTED 6 YEARS PRIOR TO THE INFECTION, THE MESH MOST LIKELY DID NOT CAUSE THE INFECTION. THE MEDICAL RECORDS ALSO INDICATE THAT THE PT HAD AND WAS TREATED FOR A RECURRENCE, WHICH IS A KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. THE REPORT DOES NOT SPECIFY A DEVICE FAILURE OR PRODUCT PROBLEM AND NO PRODUCT WAS RETURNED FO EVAL, THEREFORE, BASED ON THE CURRENT AVAILABLE INFO, THERE IS NO INDICATION THAT A FAILURE IN THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. SEE MDR 1213643-2010-00557 FOR INFO RELATED TO THE COMPOSIX KUGEL EXPLANTED ON (B)(6) 2009 WHICH HAD PREVIOUSLY BEEN REPORTED IN ACCORDANCE WITH RAE (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS PROVIDED THROUGH MEDICAL RECORDS FOR THE PT: (B)(6) 2003 - PT HAD REPAIR OF INCISIONAL HERNIA WITH BARD FLAT MESH AND AN ETHICON MESH. ON (B)(6) 2009 - PT PRESENTED TO PHYSICIAN WITH TWO SINUS TRACTS WHICH WERE OPENED AND CLEARED OF SUTURE KNOTS. THE THIRD WOUND ABOVE THE UMBILICUS WAS OPENED AND DEBRIDED TO REMOVE A PIECE OF RESIDUE OF THE MESH (IT WAS NOT CLEAR WHICH OF THE TWO PREVIOUS MESH IMPLANTS WAS INVOLVED IN THE DEBRIDEMENT AND PARTIAL EXPLANT). ON (B)(6) 2009 - PT PRESENTED TO PHYSICIAN FOR EXPLORATORY LAPAROTOMY, ADHESIOLYSIS, SMALL BOWEL RESECTION AND TAKEDOWN OF ENTEROCUTANEOUS FISTULA. PT ALSO HAD REPAIR OF RECURRENT HERNIA WITH BARD COMPOSIX KUGEL MESH (MEDWATCH: 1213643-2010-00557). ON (B)(6) 2009 - PT PRESENTED TO PHYSICIAN WITH INFECTION AND FOR REMOVAL/EXPLANT OF MESH. PT HAD DEBRIDEMENT OF ABDOMINAL WALL SKIN, MUSCLE AND FASCIA. ABDOMINAL WALL RECONSTRUCTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43GMD274

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention