BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2904556 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00076
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED VAGINAL EROSION, RECURRENT URINARY TRACT AND BLADDER INFECTIONS, MESH EROSION, BLADDER PERFORATIONS, INCONTINENCE, ABDOMINAL AND PELVIC PAIN. 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) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED VAGINAL EROSION, RECURRENT URINARY TRACT AND BLADDER INFECTIONS, MESH EROSION, BLADDER PERFORATIONS, INCONTINENCE, ABDOMINAL AND PELVIC PAIN. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10581 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 0ML9060204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other