BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2972861 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-01031
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED PAIN DUE TO THE ERODED MESH, ADDITIONAL MEDICAL TREATMENT AND PROCEDURES. ACCORDING TO THE PHYSICIAN, A FOLLOW UP MEDICAL APPOINTMENT ON (B)(6) 2009 REVEALED A MINOR PART OF THE TAPE WAS VISIBLE IN THE SUPRAPUBIC AREA. THE PHYSICIAN APPLIED A LOCAL ANESTHETIC AND EXCISED THE VISIBLE PORTION. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE IN (B)(6) 2009 (DATE UNKNOWN) TO BE EXAMINED FOR POSSIBLE VAGINAL MESH EROSION. THE PHYSICIAN PRESCRIBED ESTROGEN CREAM. THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE IN (B)(6) 2010 (DATE UNKNOWN) COMPLAINING OF CLOSURE OF THE MESH EXPOSURE. THE PHYSICIAN DID NOT PERFORM ANY PROCEDURES AND NO MEDICATION WAS PRESCRIBED. THE PATIENT RETURNED AGAIN IN (B)(6) 2010 (DATE UNKNOWN) WHERE THE MESH WAS EXCISED ONCE AGAIN. A FINAL FOLLOW UP VISIT IN (B)(6) 2010 (DATE UNKNOWN) REPORTED THE PATIENT HAD HEALED WITH NO COMPLAINTS OR EVIDENCE OF EROSION. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77154 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention