BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 7971479 · Received October 16, 2018

    Report

    Report Number
    1213643-2018-03580
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE. BASED ON THE INFORMATION PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE ALLEGED "BARD MESH" MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. MULTIPLE ATTEMPTS HAVE BEEN MADE REQUESTING ADDITIONAL INFORMATION. A LOT NUMBER WAS NOT PROVIDED, WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5079605): "IN 2012 I HAD SURGERY 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 THE USED MESH AND THEY ARGUED BACK AND FORTH AS MUCH AS TO TAKE THE CONVERSATION TO THE HALLWAY. I HAVE PAIN EVERYDAY, 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
    811822 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S