BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 1933943 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05155
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL SYSTEM WAS USED DURING A MID URETHRAL SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE NURSE OBSERVED THAT THE STERILE BARRIER HAD BEEN COMPROMISED. THE STERILE PEEL WAS SLIGHTLY OPEN AT THE CORNER. THERE WAS NO VISIBLE DAMAGE TO THE OUTER PACKAGE. THE PROCEDURE WAS COMPLETED WITH A SECOND ADVANTAGE TRANSVAGINAL SYSTEM. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502000

    Patients

    Seq Age Sex Outcome Treatment
    1