BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD AVAULTA VAGINAL MESH

    MDR report key: 2240761 · Received September 2, 2011

    Report

    Report Number
    MW5022139
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    December 21, 2007
    Report Date
    September 2, 2011
    Manufacturer
    BARD AVAULTA
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, I HAD SURGERY TO REPAIR A PROLAPSE USING BARD AVAULTA TRANSVAGINAL MESH. ON (B)(6) 2007, I GOT VERY SICK AND WAS ADMITTED TO HOSP WITH FEVER AND INFECTION. THEY HAD TO SURGICALLY PUT IN DRAIN. MY BLOOD PRESSURE DROPPED VERY LOW AND MY KIDNEYS STOPPED WORKING FOR 12 HOURS, DUE TO SEPSIS. ON (B)(6) 2007, THEY REMOVED DRAIN AND RELEASED ME FROM HOSPITAL. (B)(6) 2008, I RETURNED TO MY DR BECAUSE OF CONTINUED BLEEDING AND PAIN. HE FOUND THAT MESH HAD ERODED THROUGH VAGINAL WALL. ON (B)(6) 2008, I HAD SURGERY TO REMOVE PART OF MESH. MY FURTHER PROBLEMS FROM THE MESH INCLUDE BUT ARE NOT LIMITED TO, CONTINUED PAIN, PAIN DURING VERY LIMITED INTERCOURSE, WORRY ABOUT FURTHER PROBLEMS FROM REMAINING MESH, FEELING VERY INADEQUATE AND UNATTRACTIVE TO MY HUSBAND. PHYSICALLY AND EMOTIONALLY EXHAUSTED FROM ALL THE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD AVAULTA VAGINAL MESH VAGINAL MESH FTL BARD AVAULTA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R| S