BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVT SECUR SYSTEM

    MDR report key: 1220922 · Received November 4, 2008

    Report

    Report Number
    MW5008883
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    July 31, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ETHICON, SARL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A TVT SECURE DEVICE PLACED IN 2008. HER STRESS URINARY INCONTINENCE DID NOT IMPROVE. HER SURGEON MOVED OUT OF STATE AND SHE WAS SEEN IN FOLLOW UP BY ANOTHER PHYSICIAN WHO PERFORMED AN EXAMINATION AND FOUND A LARGE "KNUCKLE" OF MESH EXPOSED IN THE VAGINA. ESTROGEN CREAM WAS PRESCRIBED AND A UROGYNECOLOGIST WAS CONSULTED. BY THE TIME THE PT PRESENTED TO THE UROGYNECOLOGIST'S OFFICE, THE EDGE OF THE MESH WAS EXPOSED ALONG THE ENTIRE LEFT SIDE OF THE VAGINA, IN ADDITION TO THE LARGE EXTRUSION PREVIOUSLY MENTIONED. THE PT DEMONSTRATED STRESS INCONTINENCE DURING THE EXAMINATION. THE OPERATIVE REPORT FROM THE SECUR PLACEMENT WAS REVIEWED AND APPARENTLY THE DEVICE DID NOT DEPLOY APPROPRIATELY AND A SECOND DEVICE WAS USED. SHE WAS ADMITTED FOR REMOVAL OF THE MESH AND BURCH RETROPUBIC URETHROPEXY WAS PERFORMED. MESH WAS FOUND IN THE LEFT RETROPUBIC SPACE AND REMOVED. SHE REMAINED CONTINENT AT HER FIRST TWO POSTOPERATIVE EXAMINATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TVT SECUR SYSTEM TVT SECUR SYSTEM FTL ETHICON, SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| S