BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MESH MONOFILAMENT KNITTED POLYPROPYLENE

    MDR report key: 1137003 · Received August 27, 2008

    Report

    Report Number
    MW5008105
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    June 10, 2008
    Report Date
    August 19, 2008
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN EARLY 2005, I WAS IMPLANTED WITH THE BARD MESH MONOFILAMENT KNITTED POLYPROPYLENE MESH WITH PROD CODE 0112680 AND LOT # 43COD412. THE MESH WAS PLACED TO TREAT AN INCISIONAL HERNIA. IN 2006, I WAS IMPLANTED WITH THE PROLENE HERNIA SYS WITH LOT NUMBER 14132-02. THE MESH WAS PLACED TO TREAT ANOTHER INCISIONAL HERNIA. IN 2008, I UNDERWENT SURGERY TO HAVE BOTH MESHES ABOVE REMOVED. BOTH MESHES WERE BALLED UP INTO A HEAP OF SCAR TISSUE. IN ADDITION, THE FALCIFORM LIGAMENT WAS GOING INTO PART OF THE BALLED UP MESH SO THE LIGAMENT HAD TO BE DIVIDED AND CUT OUT OF THE MESH. THE DEFECT INSIDE MY ABDOMEN WAS 14 CM IN LENGTH AND 6 CM IN WIDTH. DATES OF USE: 2005, 2006. DIAGNOSIS OR REASON FOR USE: TREAT INCISIONAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD MESH MONOFILAMENT KNITTED POLYPROPYLENE MESH PRODUCT FTL BARD 43COD412
    2 BARD MESH MONOFILAMENT KNITTED PLOYPROPYLENE PROLENE HERNIA SYSTEM FTL BARD 14132-02

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R