BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2132632 · Received June 17, 2011

    Report

    Report Number
    3005099803-2011-01995
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX CURVED TRANSOBTURATOR MIDURETHRAL SLING SYSTEM WAS USED DURING A TRANSOBTURATOR SLING PROCEDURE ON (B)(6), 2006. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH BLOOD IN HER URINE. THE PATIENT HAD A PELVIC EXAM ON THE SAME DAY AND THE NURSE NOTED THAT A PORTION OF THE BLUE CENTERING TAB OF THE SLING WAS VISIBLE FROM THE VAGINAL INCISION. THE NURSE THEN PULLED OUT THE TAB BY HAND AND NO FURTHER SURGERY WAS REQUIRED. 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 M0068504000 0ML6030802

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention