BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD VISILEX MESH

    MDR report key: 1232231 · Received November 13, 2008

    Report

    Report Number
    MW5008990
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    March 18, 2008
    Report Date
    November 13, 2008
    Manufacturer
    DAVOL, INC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2003, PT HAD BILATERAL INGUINAL HERNIA REPAIR WITH MESH. BARD VISILEX MESH WAS USED ON HIS RIGHT AND LEFT SIDES. IN 2008, PT PRESENTED WITH PROSTATE CANCER FOR A RADICAL PROSTATECTOMY. UNFORTUNATELY, THE ANTERIOR ASPECT OF THE BLADDER WAS VERY ADHERENT TO THE MESH, AND WE WERE UNABLE TO GET AN ADEQUATE PLANE BETWEEN THE DETRUSOR AND THE MESH. BECAUSE OF THIS SIGNIFICANT ANTERIOR ADHERENCE, THE SURGEON DID NOT FEEL WE COULD SAFELY PROCEED WITH PROSTATECTOMY. THE PT WAS CLOSED AND RADIATION THERAPY WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD VISILEX MESH SIZE 4.5 INCHES XREF 0112910 6 INCHES FTL DAVOL, INC 43END199
    2 BARD VISILEX MESH SIZE 4.5 INCHES XREF 0112910 6 INCHES FTL DAVOL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR