BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 1220672 · Received November 3, 2008

    Report

    Report Number
    MW5008846
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    July 23, 2004
    Report Date
    November 3, 2008
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BARD PERMANENT MESH PLACED FOR TRANSVAGINAL AP REPAIR. EROSION OF VAGINAL WALL OCCURRED LESS THAN ONE YEAR AFTER PLACEMENT OF PERMANENT MESH. HAVE HAD 4 CORRECTIVE SURGERIES AND CONTINUE TO HAVE EROSION OF ANTERIOR VAGINAL WALL WITH INCREASE IN SCAR TISSUE & INCREASE OF INCONTINENCE SYMPTOMS WITH EACH REMOVAL OF PIECE OF EXPOSED MESH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization