BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM - CURVED

    MDR report key: 1143706 · Received August 29, 2008

    Report

    Report Number
    3005099803-2008-04210
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINANT WAS THE PT WHOSE NAME AND TELEPHONE NUMBER IS NOT BEING SUBMITTED. THE ADDITIONAL INFO WAS OBTAINED FROM HER PHYSICIAN. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN OBTRYX/LYNX SLING WAS USED DURING A PARAVAGINAL URETHRAL SLING PROCEDURE ON THE PREVIOUS MONTH. ACCORDING TO THE COMPLAINANT, A PARAVAGINAL URETHREAL SLING WAS PLACED IN TWO MONTHS PRIOR TO ORIGINAL DATE, DAY IS UNKNOWN. ON THE MONTH PRIOR TO ORIGINAL MONTH, THE DOCTOR HAD TO GO BACK IN (SURGERY) DUE TO AN EROSION OF THE VAGINAL WALL. THE SKIN DID NOT CLOSE OVER THE SLING AND THERE WERE NOT SIGNS OF INFECTION. ON THE DAY PRIOR TO ORIGINAL DATE, THE PT WENT BACK TO THE DOCTOR AND THE SKIN STILL HAD NOT CLOSED UP. THE PATIENT'S GYNECOLOGIST STATED THAT ANY ADDITIONAL FOLLOW-UP WILL BE WITH HER UROLOGIST. UROLOGIST NAME HAS NOT BEEN PROVIDED. NO ADDITIONAL PT DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM - CURVED FTL BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention