BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 1792113 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03529
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS USED DURING A RETROPUBIC SLING INSERTION PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, OUTSIDE THE PATIENT, AS THE BLUE DILATOR WAS BEING LOADED ON TO THE DELIVERY NEEDLE, THE SLEEVE COVERING THE MESH TORE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER ADVANTAGE FIT SYSTEM. THE CONDITION OF THE PATIENT FOLLOWING THE EVENT WAS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110 1ML0011813

    Patients

    Seq Age Sex Outcome Treatment
    1