BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2780154 · Received October 10, 2012

    Report

    Report Number
    3005099803-2012-04579
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SUFFERED CHRONIC PAIN AND RECURRENCE OF STRESS URINARY INCONTINENCE. ACCORDING TO THE PHYSICIAN'S OFFICE, NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED RELATED TO THE MESH. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 1ML0050301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other