BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL INC., BARD MESH

    MDR report key: 948029 · Received November 12, 2007

    Report

    Report Number
    MW5004411
    Event Type
    Injury
    Date Received
    November 12, 2007
    Date of Event
    July 23, 2003
    Report Date
    November 12, 2007
    Manufacturer
    DAVOL, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REALIZE THAT CERTAIN KUGEL MESH LOTS HAVE BEEN RECALLED, BUT I HAVE ON GOING PROBLEMS, FISTULAE, INFECTIONS, NO ABDOMINAL WALL. I ALSO HAVE OPEN WOUNDS, THAT I HAVE HAD 3 SKIN GRAFTS, THAT BECAUSE THE MESH CONTINUES TO BREAK THROUGH THE SKIN GRAFTS HAVE NOT TAKEN. I AM A MALE WITH SERIOUS PROBLEMS ALL DUE TO COMPOSIX KUGEL MESH. HERE ARE MY BARD MESH MANUFACTURED BY DAVOL, LOT NUMBERS QUANTITY 4 LOT NUMBER 43BND061, 43HMD020, 43END207, THE CORRESPONDING CATALOG NUMBERS 0112670 SIZE 2X12, 0112670, SIZE 2X12, 0113112 SIZE 12X12. MESH MARLEX 10X14, MESH TRELEX 3X6, MESH MARLEX 2X12, MESH COMPOSIX 12X12. PLEASE NOTE THAT MY WIFE TREATS MY WOUNDS DAILY AND CONTINUES TO CUT AND REMOVE MESH FROM MY OPEN WOUNDS. OTHER EXP DATES: 02/28/2008, 08/03/2007. DATES OF USE: 2003 - 2007. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO. EVENT REAPPEARED AFTER REINTRODUCTION: 1. YES, 2. YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL INC., BARD MESH COMPOSIX KUGEL MESH FTL DAVOL, INC. * 43END207
    2 DAVOL INC., BARD MESH COMPOSIX KUGEL MESH FTL DAVOL, INC. 43HMD020
    3 DAVOL INC., BARD MESH COMPOSIX KUGEL MESH FTL DAVOL, INC. 43BND061

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R| S