BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT MESH

    MDR report key: 2831971 · Received November 13, 2012

    Report

    Report Number
    MW5027599
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    December 23, 2003
    Report Date
    November 13, 2012
    Manufacturer
    GYNECARE
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MESH IMPLANTED ON (B)(6), 2003 DUE TO INCONTINENCE. THEREAFTER, EVERY MONTH DURING HER MENSTRUAL CYCLE, FEELS LIKE SHE IS ALMOST HEMORRHAGING BECAUSE SHE HAS TO CHANGE 2-3 PADS EVERY 1-2 HOUR. HAVING CRAMPING, ABDOMINAL PAIN, SWELLING AROUND THE SUTURE SITE, TENDERNESS, AND DISCOMFORT DURING INTERCOURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVT MESH MESH FTL GYNECARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other