BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2991624 · Received March 6, 2013

    Report

    Report Number
    3005099803-2013-01070
    Event Type
    Injury
    Date Received
    March 6, 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
    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) 2009. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN, THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. DURING A FOLLOW UP MEDICAL APPOINTMENT ON (B)(6) 2010, NO PATIENT COMPLICATIONS WERE REPORTED. NO EVIDENCE OF EROSION WAS PRESENT AND THE PATIENT HAD EXCELLENT BLADDER CONTROL. THE PATIENT HAS NOT BEEN SEEN SINCE THE (B)(6) 2010 APPOINTMENT. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95563 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other