BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE TRANSVAGINAL SYSTEM

    MDR report key: 1550997 · Received December 2, 2009

    Report

    Report Number
    3005099803-2009-05695
    Event Type
    Injury
    Date Received
    December 2, 2009
    Report Date
    November 5, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN ADVANTAGE TRANSVAGINAL SYSTEM WAS USED DURING AN UNK PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, AFTER THE PROCEDURE, THE PT PRESENTED WITH EROSION. SEVERAL ATTEMPTS AT F/U HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE TRANSVAGINAL SYSTEM FTL BOSTON SCIENTIFIC CORP M0068502000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other