BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2851592 · Received November 29, 2012

    Report

    Report Number
    3005099803-2012-05710
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. THE IMPLANTATION DATES PROVIDED ARE (B)(6), 2010 AND (B)(6), 2011, BUT IT WAS NOT SPECIFIED ON WHICH DATE THE DEVICE WAS IMPLANTED.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS.ALL OTHER INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH THE OBTRYX DEVICE ON (B)(6) 2010. IN (B)(6) OF 2011, THE PATIENT WAS SEEN BY THE IMPLANTING PHYSICIAN, AND COMPLAINED OF CONTINUED LEAKING. THE PHYSICIAN DIAGNOSED THAT SHE HAD A LITTLE BIT OF A URETHROCELE, AND REFERRED THE PATIENT TO ANOTHER PHYSICIAN, WHO IMPLANTED AN AMS INTE XEN DEVICE. ACCORDING TO THIS SECOND PHYSICIAN, THE PATIENT'S URETHROCELE DID NOT SEEM TO BE RELATED TO THE OBTRYX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other