BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2221364 · Received August 24, 2011

    Report

    Report Number
    3005099803-2011-02962
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    September 23, 2010
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS USED DURING A SLING PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED LEG PAIN FOR ONE WEEK POST PROCEDURE. THE PHYSICIAN PERFORMED A DOPPLER TEST FOR THE PATIENT'S ARTERIES AND VEINS IN THE LEGS AND THE TEST RESULTS WERE NEGATIVE. THE PATIENT BEGAN SEEING A CHIROPRACTOR (DATE AND DURATION UNKNOWN) WHO ADVISED THAT THE PAIN IS MOST LIKELY RELATED TO THE PATIENT'S CHRONIC BACK PAIN. ON (B)(6) 2011, THE PATIENT REPORTED TO THE PHYSICIAN THAT SINCE THE CHIROPRACTOR VISITS, THE LEG PAIN HAS SUBSIDED SIGNIFICANTLY. THE PHYSICIAN HAS NOT PLANNED ANY FURTHER MEDICAL INTERVENTION AND THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "FINE."

    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