BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2223284 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02883
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    March 18, 2008
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX TRANSOBTURATOR MIDURETHRAL SLING SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. THERE WERE NO COMPLICATIONS DURING THIS PROCEDURE. THE PATIENT REPORTED THAT ALMOST IMMEDIATELY POST PROCEDURE, SHE EXPERIENCED THE FOLLOWING: PAIN WHILE SITTING, DYSPAREUNIA, BLADDER INFECTIONS AND RETENTION. THE PATIENT WAS PRESCRIBED MEDICATION FOR BLADDER INFECTIONS ON SEVERAL OCCASIONS (EXACT DATE AND DURATION UNKNOWN) AND VICODIN AND PYRIDIUM FOR THE PAIN. THE PATIENT WAS ADVISED TO HAVE A PARTIAL SLING REMOVAL, BUT HAS NOT HAD A REMOVAL SURGERY. THE PATIENT IS CURRENTLY STABLE, BUT REPORTED THAT THE PAIN STILL EXISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR