BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2900449 · Received January 7, 2013

    Report

    Report Number
    3005099803-2012-06412
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INTO THE PATIENT ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED VAGINAL INFECTIONS, DYSPAREUNIA, LOCALIZED PELVIC PAIN, DISFIGUREMENT AND RECURRENCE OF STRESS URINARY INCONTINENCE AND/OR PELVIC ORGAN PROLAPSE. THE PHYSICIAN'S OFFICE WAS CONTACT; IT WAS STATED THAT AS FAR AS THE DOCTOR KNOWS, THE PATIENT DI NOT EXPERIENCE ANY COMPLICATIONS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7594 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068504000 0ML8091101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other