BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX II SYSTEM

    MDR report key: 4170591 · Received October 14, 2014

    Report

    Report Number
    3005099803-2014-03304
    Event Type
    Injury
    Date Received
    October 14, 2014
    Date of Event
    February 11, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 OBTRYX II, HALO, WAS USED DURING A TRANSOBTURATOR INSERTION PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED IMMEDIATELY AT THE CONCLUSION OF THE PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT DEVELOPED MESH EROSION POST IMPLANTATION. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651256 OBTRYX II SYSTEM MESH, SURGICAL, SYNTHETIC OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068505110 ML00001429

    Patients

    Seq Age Sex Outcome Treatment
    1 Other