BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2961244 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00868
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 TENSION-FREE VAGINAL TAPE (TVT) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). ACCORDING TO THE PHYSICIAN, AT THE INITIAL FOLLOW-UP APPOINTMENT ON (B)(6) 2011, THE PATIENT PRESENTED WITH VAGINAL DISCHARGE AND MILD RIGHT-SIDED PAIN AT THE INCISION SITE. AT THE SIX-WEEK FOLLOW-UP APPOINTMENT ON (B)(6) 2011, THE PATIENT PRESENTED WITH A SINUS INFECTION AND A YEAST INFECTION. ON (B)(6) 2012, THE PATIENT COMPLAINED OF BURNING DISCOMFORT AND DISCHARGE (VESTIBULITIS), BUT NO VAGINAL TENDERNESS WAS REPORTED. THE PHYSICIAN NOTED THE PRESENCE OF CLITORAL LICHEN SCLEROSUS AND PRESCRIBED CLIONASTEROL. A FOLLOW-UP EXAMINATION ON (B)(6) 2012 REVEALED THAT THE LICHEN SCLEROSUS WAS STILL PRESENT; THEREFORE, TESTOSTEROL CREAM WAS ADDED TO THE REGIMEN. ON (B)(6) 2012, THE LICHEN SCLEROSUS WAS FOUND TO HAVE MARKEDLY IMPROVED. THE PATIENT WAS LAST SEEN ON (B)(6) 2012 WITH NO FURTHER PROBLEMS OR COMPLAINTS REPORTED. 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
    65156 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other