BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2780887 · Received October 10, 2012

    Report

    Report Number
    3005099803-2012-04630
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT SUFFERED SEVERE PAIN IN THE RIGHT GROIN, MESH EXPOSURE, EROSION, EXTRUSION, PROTRUSION, SEVERE PELVIC AND ABDOMINAL PAIN. THE PATIENT ALSO EXPERIENCED INFLAMMATION OF THE PUBIS AREA, ABNORMAL BLEEDING, VAGINAL DISCHARGE AND DYSPAREUNIA. ACCORDING TO THE PHYSICIAN'S OFFICE, AS OF SEVERAL FOLLOW UP MEDICAL APPOINTMENTS, NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other