BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 3944897 · Received July 18, 2014

    Report

    Report Number
    3005099803-2014-02501
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE MESH ROLLED UP AND THERE WAS FRAYING AT THE EDGES. THE PHYSICIAN REMOVED THE FIRST SLING AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANTAGE FIT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421928 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068502110 ML00002036

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR