BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 2962421 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00707
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING AN ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING SYSTEM, AS THE PHYSICIAN WAS PALPATING WITH HIS FINGER, HE PERFORATED THE BLADDER. THE PHYSICIAN BELIEVES THAT THE PERFORATION WAS LIKELY CAUSED BY HIS FINGER, BUT DEFINITELY NOT THE ADVANTAGE DEVICE OR TROCAR. THE PHYSICIAN REPAIRED THE PERFORATION USING SUTURES AND ABORTED THE PROCEDURE WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64733 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention