BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 2770085 · Received October 3, 2012

    Report

    Report Number
    3005099803-2012-04410
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT DATE OF THE ADVANTAGE DEVICE IS UNKNOWN; HOWEVER IT MUST HAVE BEEN AFTER THE MANUFACTURE DATE OF (B)(4) 2008. THEREFORE, THE IMPLANT DATES LISTED IN "OTHER RELEVANT HISTORY" REFER TO PREVIOUSLY IMPLANTED DEVICES, INCLUDING THE AMS PRODUCTS.

    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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED PAIN AND DISABILITY. 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 FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110 0ML8082001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other