BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 4123045 · Received September 26, 2014

    Report

    Report Number
    3005099803-2014-03192
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    February 17, 2009
    Report Date
    September 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO SINGLE SYSTEM DEVICE WAS USED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2009, THE PATIENT EXPERIENCED PAIN IN THE RECTUM, VAGINA, THIGHS AND BUTTOCKS, DYSPAREUNIA, SCAR TISSUE AND NERVE DAMAGE. THE SLING COULD BE FELT MANUALLY IN THE VAGINA. THE PATIENT HAD TWO SURGERIES TO REMOVE THE SLING AND TWO OTHER MORE TO CORRECT BLADDER ISSUES. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600752 OBTRYX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068505000 0ML8102801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention