BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 3180798 · Received June 20, 2013

    Report

    Report Number
    3005099803-2013-04893
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT DID NOT REPORT ANY COMPLAINTS OR PRESENT WITH ANY COMPLICATIONS DURING HER FIRST POST-OPERATIVE FOLLOW-UP ON AN UNKNOWN DATE. IN (B)(6) 2012, THE PATIENT COMPLAINED OF PELVIC PAIN, STRESS URINARY INCONTINENCE, SPOTTING, AND DYSPAREUNIA. THE PHYSICIAN NOTED SOME CRACKING IN THE VAGINA, AND PRESCRIBED VESICARE. THE PHYSICIAN SAW THE PATIENT FOR THE LAST TIME IN (B)(6) 2012, WHEN SHE COMPLAINED THAT SHE'D HAD FIVE URINARY TRACT INFECTIONS DURING THE PREVIOUS SIX MONTHS. SHE ALSO REPORTED SHE WAS STILL HAVING PAIN WITH SEX. A URINALYSIS WAS PERFORMED AND WAS POSITIVE FOR (B)(6), FOR WHICH THE PATIENT WAS GIVEN ANTIBIOTICS. THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN TO BE TESTED FOR INTERSTITIAL CYSTITIS, BUT IT IS UNKNOWN IF SHE FOLLOWED UP. 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
    280199 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention