BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2863083 · Received December 10, 2012

    Report

    Report Number
    3005099803-2012-05887
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER, 0ML9102603, COULD NOT BE MATCHED TO THE REPORTED DEVICE. THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE PHYSICIAN, POST PROCEDURE, THE PATIENT EXPERIENCED PAIN DOWN ONE OF HER LEGS. THE OBTRIX WAS REMOVED ON AN UNKNOWN DATE; HOWEVER A SECOND PROCEDURE (DATE UNKNOWN) WAS NECESSARY TO REMOVE REMAINING MESH FRAGMENTS. THE PATIENT RETURNED LATER (DATE UNKNOWN), COMPLAINING OF LEAKING URINE. THE PATIENT HAS NOT BEEN SEEN SINCE (B)(6) 2011. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED EROSION, DYSPAREUNIA, ABDOMINAL PAIN AND PELVIC PAIN. ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other