BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2904874 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00145
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 24, 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 INTO THE PATIENT ON (B)(6), 2007. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED SERIOUS BODILY INJURIES, EXTREME PHYSICAL AND MENTAL PAIN, PELVIC PAIN, ENLARGED PELVIC LYMPH NODES, NAUSEA, CRAMPING, DYSPAREUNIA, BLEEDING, DISCHARGE, PAIN ABOVE THE TAILBONE, EROSION OF THE MESH AND OTHER INJURIES.ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10641 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 0ML6090713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other