BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 1338315 · Received March 8, 2009

    Report

    Report Number
    MW5010246
    Event Type
    Injury
    Date Received
    March 8, 2009
    Date of Event
    March 28, 2007
    Report Date
    March 8, 2009
    Manufacturer
    C.R. BARD INC, BARD UROLOGICAL DIVISION
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2007, I HAD SURGERY FOR A PROLAPSED UTERUS. THE PRODUCT USED WAS BARD AVAULTA, A PERMANENT SURGICAL MESH IMPLANT. I HAVE HAD FIVE ADDITIONAL SURGERIES SINCE TO TRY AND CORRECT THE ISSUES THE MESH CAUSED. I HAVE CONSTANT PAIN AND HAVE BEEN TOLD IT IS DUE TO THE MESH INSIDE OF ME, THAT IT MUST COME OUT. IM NOW GOING TO NEED TO GO THROUGH A SEVENTH SURGERY AND POSSIBLY MORE. THIS PRODUCT NEEDS TO BE RECALLED AND OFF THE MARKET. NO WOMAN SHOULD HAVE TO SUFFER LIKE THIS. I URGE YOU TO PLEASE RECALL THIS MESH BEFORE MORE PEOPLE HAVE ISSUES LIKE MINE. THANK YOU, DATES OF USE: 2007- 2009, DIAGNOSIS OR REASON FOR USE: PROLAPS UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD AVAULTA FTL C.R. BARD INC, BARD UROLOGICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L BARD AVAULTA