BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2992563 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01120
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. DURING THE TWO AND SIX WEEK FOLLOW UP MEDICAL APPOINTMENTS, NO PROBLEMS OR COMPLAINTS WERE REPORTED. ON (B)(6) 2012, THE PATIENT REPORTED LOWER ABDOMINAL PAIN. HOWEVER, THE PHYSICIAN COULD NOT GET ANY OF THE PAIN EXCEPT FOR THE LOWER BACK TO PALPATE. THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN WHERE AN X-RAY OF THE LUMBAR AND THORACIC BACK WAS PERFORMED. NO EROSION WAS OBSERVED. THE PATIENT DID NOT ATTEND A FOLLOW UP APPOINTMENT SCHEDULED IN (B)(6) 2012. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96753 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other