BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 3013569 · Received March 20, 2013

    Report

    Report Number
    3005099803-2013-01423
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, AS A RESULT OF THE IMPLANT, THE PATIENT SUFFERS PAIN, SUFFERING, DISABILITY, IMPAIRMENT, LOSS OF ENJOYMENT OF LIFE, AND INABILITY TO ENGAGE IN CHOSEN AND NECESSARY ACTIVITIES. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115453 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ETHICON TENSION-FREE VAGINAL TAPE