BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 6122356 · Received November 22, 2016

    Report

    Report Number
    1213643-2016-00536
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    June 22, 2009
    Report Date
    October 31, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. WITH THE CURRENT INFORMATION AVAILABLE NO CONCLUSION CAN BE MADE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2008 - THE PATIENT WAS DIAGNOSED WITH SUI AND CYSTOCELE. THE PATIENT UNDERWENT REPAIR OF CYSTOCELE USING A DAVOL FLAT MESH AS A HAMMOCK TO SUPPORT THE BLADDER AND A NON BARD DAVOL TVTO SLING TO TREAT THE URINARY INCONTINENCE. ON (B)(6) 2009 - THE PATIENT UNDERWENT EXPLANT OF THE DAVOL FLAT MESH TRANSVAGINALLY. THE FLAT MESH WAS NOTED TO BE ERODING THROUGH THE ANTERIOR VAGINAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773796 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 43BOD039

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention