BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2800397 · Received October 22, 2012

    Report

    Report Number
    3005099803-2012-04842
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN). ALL OTHER INFORMATION, INCLUDING THE PATIENT'S CURRENT CONDITION, IS UNKNOWN AND REPORTEDLY 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