BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 2891178 · Received December 31, 2012

    Report

    Report Number
    3005099803-2012-06398
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN, MESH EROSION, RECURRENT URINARY TRACT INFECTIONS (UTIS), AND THE RETURN OF SUDDEN URINARY INCONTINENCE (SUI) AND PROLAPSE.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
    1 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502111 0ML9111602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other