BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 2882284 · Received December 20, 2012

    Report

    Report Number
    3005099803-2012-06226
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    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 DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED SWELLING ON HER LEFT SIDE AND PELVIC PAIN. THE PHYSICIAN RAN SOME UNSPECIFIED TESTS AND DID NOT FIND AN ISSUE WITH THE DEVICE. REPORTEDLY, THE PATIENT, WHO IS OVER 18 YEARS OF AGE, WAS REFERRED TO PAIN MANAGEMENT (SPECIFICS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other