BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 1974558 · Received January 31, 2011

    Report

    Report Number
    3005099803-2011-00253
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, SO THE ROOT CAUSE WAS UNDETERMINABLE. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT TRANSVAGINAL SLING SYSTEM WAS UNPACKED FOR A CYSTOCELE REPAIR PROCEDURE. ACCORDING TO THE COMPLAINANT, THERE WAS A PERFORATION OF THE INNER PACKAGING OF THE DEVICE IN AN AREA OTHER THAN THE SEAL AND THE STERILITY OF THE DEVICE APPEARED COMPROMISED. IT IS UNKNOWN WHETHER THE OUTER BOX WAS DAMAGED. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER ADVANTAGE FIT TRANSVAGINAL SLING SYSTEM AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT TRANSVAGINAL SLING SYSTEM WAS UNPACKED FOR A CYSTOCELE REPAIR PROCEDURE. ACCORDING TO THE COMPLAINANT, THERE WAS A PERFORATION OF THE INNER PACKAGING OF THE DEVICE IN AN AREA OTHER THAN THE SEAL AND THE STERILITY OF THE DEVICE APPEARED COMPROMISED. IT IS UNKNOWN WHETHER THE OUTER BOX WAS DAMAGED. THE DEVICE WAS NOT USED FOR THE PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER ADVANTAGE FIT TRANSVAGINAL SLING SYSTEM 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 FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502111 1ML0071902

    Patients

    Seq Age Sex Outcome Treatment
    1