BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 3173885 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05229
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    December 16, 2012
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED ON (B)(6) 2012. AT SOME POINT AFTER THE PROCEDURE, THE PATIENT EXPERIENCED URINE LEAKAGE. ADDITIONALLY, ON (B)(6) 2012 AN ULTRASOUND AND CT SCAN (PERFORMED FOR REASONS UNKNOWN) REVEALED A HEMATOMA ON THE RIGHT SIDE OF THE PELVIS WHICH LATER RESOLVED. THE PHYSICIAN OPINES THAT THE HEMATOMA WAS CAUSED WHEN HE PLACED THE RIGHT SIDE NEEDLE TIP SLIGHTLY MORE LATERALLY THAN USUAL. REPORTEDLY, THE PHYSICIAN IS TAKING A WAIT-AND-SEE APPROACH WITH CONSERVATIVE THERAPY (SPECIFICS UNKNOWN). NO FURTHER INFORMATION IS AVAILABLE, THE PATIENT IS CURRENTLY BEING MONITORED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273634 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention