BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 3191151 · Received June 26, 2013

    Report

    Report Number
    3005099803-2013-05103
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 3, 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 FIT SYSTEM WAS IMPLANTED (B)(6) 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN¿S OFFICE, THE PATIENT WAS SEEN APRIL 30, 2013 AND PRESENTED WITH URINARY TRACT INFECTIONS (UTI¿S) SINCE THE SURGERY. THE PATIENT WAS REFERRED TO A SPECIALIST AND HAS NOT BEEN SEEN SINCE. 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
    290758 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other