BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD MESH IMPLANT

    MDR report key: 7850721 · Received September 5, 2018

    Report

    Report Number
    MW5079605
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    April 13, 2012
    Report Date
    August 31, 2018
    Manufacturer
    C. R. BARD, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2012, I HAD SURGERY AT (B)(6) FOR UMBILICAL HERNIA AND THEY IMPLANTED BARD MESH. I NEVER WAS STILL SPOKE TO OR ASKED ABOUT PREVIOUSLY ABOUT MESH, WHEN I WENT BACK TO THE HOSP FOR MY F/U, I ASKED THE SURGEON AND ASSISTANT IF THEY USED MESH AND THEY ARGUED BACK AND FORTH AS MUCH AS TO TAKE THE CONVERSATION TO THE HALLWAY. I HAVE PAIN EVERY DAY, EVERY MOMENT WITH FULL OF PAIN. IT HAS COST ME A LIFETIME OF LOST TIME WITH MY FAMILY. I CAN NEVER DESCRIBE THE PAIN, IT CAUSED AS I CANNOT HAVE AN INTIMATE RELATIONSHIP OR EVEN GO TO THE GROCERY STORE WITHOUT HAVING SO MUCH PAIN OR HAVE URINATING WHILE TRYING TO SHOP BECAUSE MY BLADDER JUST HAS SPASMS AND I DON'T KNOW WHEN I HAVE TO GO. IT HAS BEEN 6 YEARS I'M ON PERMANENT DISABILITY. I'VE MISSED ALL FIVE OF MY CHILDREN GROWING UP. I'VE LOST MY HUSBAND AND I HAVE AN ENORMOUS AMOUNT OF PAIN EVERYDAY, ALL DAY, AND EVERY MOMENT. I RECENTLY DID AN MRI AND IT SHOWS THE MESH NEEDS TO BE REMOVED SO I WILL BE DOING THAT AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688544 BARD MESH IMPLANT MESH, SURGICAL, POLYMERIC FTL C. R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R| S