BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1572131 · Received January 5, 2010

    Report

    Report Number
    3005099803-2010-00027
    Event Type
    Injury
    Date Received
    January 5, 2010
    Report Date
    December 18, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A TRANSVAGINAL SLING SYSTEM WAS USED BUT THE BRAND NAME OF THE DEVICE IS UNAVAILABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE FTL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other