BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2491677 · Received March 14, 2012

    Report

    Report Number
    3005099803-2012-00999
    Event Type
    Injury
    Date Received
    March 14, 2012
    Report Date
    February 21, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL SLING SYSTEM WAS USED DURING A TVT PROCEDURE ON (B)(6), 2005. ACCORDING TO THE COMPLAINANT, TWO TO THREE YEARS POST PROCEDURE, THE PATIENT EXPERIENCED DYSPAREUNIA AND CHRONIC VAGINAL YEAST AND BACTERIAL INFECTIONS. WHEN APPLYING MEDICINAL CREAM TO THE VAGINA, THE PATIENT FELT A HARD, ROUGH SURFACE ON THE VAGINAL WALL. DURING AN EXAM, THE PHYSICIAN FOUND MESH EROSION (EXACT DATE UNKNOWN). THE PATIENT WAS THEN REFERRED TO A DIFFERENT PHYSICIAN WHO REMOVED THE ERODED MESH. THE DETAILS OF THE REMOVAL SURGERY ARE UNKNOWN. ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL SLING SYSTEM WAS USED DURING A TVT PROCEDURE ON (B)(6) 2005. ACCORDING TO THE COMPLAINANT, TWO TO THREE YEARS POST PROCEDURE, THE PATIENT EXPERIENCED DYSPAREUNIA AND CHRONIC VAGINAL YEAST AND BACTERIAL INFECTIONS. WHEN APPLYING MEDICINAL CREAM TO THE VAGINA, THE PATIENT FELT A HARD, ROUGH SURFACE ON THE VAGINAL WALL. DURING AN EXAM, THE PHYSICIAN FOUND MESH EROSION (EXACT DATE UNKNOWN). THE PATIENT WAS THEN REFERRED TO A DIFFERENT PHYSICIAN WHO REMOVED THE ERODED MESH. THE DETAILS OF THE REMOVAL SURGERY ARE UNKNOWN.ALL OTHER INFORMATION 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 M0068502000 0ML5033101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention