BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 2883982 · Received December 21, 2012

    Report

    Report Number
    3005099803-2012-06229
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6) 2012. THE PATIENT WENT HOME WITH A CATHETER BUT EXPERIENCED DIFFICULTY URINATING, WITH POOR URINARY STREAM AND INTERMITTENT URINARY RETENTION. DUE TO THESE COMPLICATIONS, THE PHYSICIAN PERFORMED A TRANSVAGINAL URETHROLYSIS ON THE PATIENT. IMMEDIATELY AFTER THE TRANSVAGINAL URETHROLYSIS, THE PATIENT STILL EXPERIENCED DIFFICULTY URINATING. SHE WENT HOME, BUT RETURNED TO THE EMERGENCY ROOM LATER THAT DAY BECAUSE OF VERY POOR STREAM AND URINARY RETENTION, AND WAS CATHETERIZED WITH A FOLEY CATHETER. THE PATIENT RETURNED THE NEXT DAY AND HAD THE FOLEY CATHETER REMOVED. SINCE THEN, SHE STILL REPORTEDLY HAS INTERMITTENT POOR URINARY STREAM AND HAS TO STRAIN TO URINATE, WHICH CAUSES HER PAIN IN THE VAGINAL AREA. THE PATIENT WENT TO ANOTHER UROLOGY OFFICE, AND WAS TOLD THAT THE ROUGH TEXTURE SHE CAN FEEL INSIDE HER VAGINA IS THE ADVANTAGE MESH UNDER THIN SKIN (SPECIFICS UNKNOWN). THE PATIENT REPORTEDLY HAD A GRANULOMA REMOVED (SPECIFICS UNKNOWN) AND CONTINUES TO HAVE VAGINAL PAIN THAT RADIATES TOWARD HER RECTUM AND LEFT THIGH, AND PAIN WHEN STRAINING TO URINATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention