BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2233226 · Received September 2, 2011

    Report

    Report Number
    3005099803-2011-02992
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    April 21, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PROCEDURE WAS A TRANSVAGINAL MESH FOR STRESS URINARY INCONTINENCE PROCEDURE. THE INITIAL PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION IMMEDIATELY POST PROCEDURE WAS REPORTED TO BE "OKAY." THE PATIENT AGE WAS REPORTED TO BE OVER 18. THE IMPLANTING PHYSICIAN REPORTED THAT THE PATIENT'S STITCHES DID NOT HOLD AND THAT THE MESH WAS EXPOSED RATHER THAN ERODED. THE PATIENT DID NOT REPORT ANY LEG SWELLING TO THE PHYSICIAN AND WAS NOT PRESCRIBED ANY MEDICATION FOR SWELLING. IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PATIENT IN (B)(6) 2011. THE PHYSICIAN DOES NOT PLAN ON PROVIDING FURTHER MEDICAL INTERVENTION AND THE PATIENT'S CARE HAS BEEN TRANSFERRED TO ANOTHER PHYSICIAN. THE PATIENT WAS REPORTED TO BE OBESE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM WAS USED DURING A PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, IMMEDIATELY POST PROCEDURE, THE PATIENT FELT UNWELL. THE PATIENT EXPERIENCED EROSION, GROIN PAIN, LEG SWELLING, BLADDER AND BOWEL PROBLEMS, DIZZY SPELLS, CONSTANT PAIN, AND WORSE LEAKAGE. THE DATE OF ONSET FOR EACH IS UNKNOWN. IT WAS REPORTED THAT PART OF THE DEVICE WAS REMOVED AT AN UNKNOWN DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068504000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other