BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 2893957 · Received December 27, 2012

    Report

    Report Number
    MW5028402
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    May 21, 2011
    Report Date
    December 27, 2012
    Manufacturer
    BARD - JOHNSON & JOHNSON
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD 2 BARD 3D MESHES IMPLANTED FOR A DOUBLE HERNIA AND THE MESH RUBBED A HOLE IN MY BLADDER ABOUT THE SIZE OF A 50 CENT PIECE AND BECAME INFECTED WITH STAPH INFECTION ALMOST RESULTING IN MY DEATH. THE MESH HAD TO BE REMOVED AND WAS SO FULL OF STAPH INFECTION IT INFECTED MY INCISION. IT WAS NOT BEEN RECALLED AS FAR AS I KNOW AND SHOULD BE BEFORE SOMEONE DIES AS A RESULT OF THIS DEFECTED PRODUCT. I AM PERMANENTLY SCARRED FROM MY BELLY BUTTON TO MY CROTCH WITH WHAT LOOKS LIKE A SECOND BELLY BUTTON WHERE THE INCISION SPLIT OPEN FROM THE INFECTION. LAWYERS WON'T TAKE THE CASE BECAUSE THE LOT # HAS NOT BEEN RECALLED. MY E-MAIL IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD BARD 3D MESH FTL BARD - JOHNSON & JOHNSON
    2 BARD BARD 3D MESH FTL BARD - JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| O| R| S