BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 3150184 · Received June 6, 2013

    Report

    Report Number
    3005099803-2013-04134
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO THREE OF THREE DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-04954 AND ASSOCIATED MANUFACTURER REPORT # 3005099803-2013-04955 PERTAIN TO THE OTHER DEVICES. 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. 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
    251022 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502000 0ML9041501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PINNACLE ANTERIOR-APICAL PELVIC FLOOR REPAIR KIT| PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT