BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 3971603 · Received July 31, 2014

    Report

    Report Number
    3005099803-2014-02605
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    March 21, 2012
    Report Date
    July 7, 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

    THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. 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 SYSTEM WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS UNABLE TO VOID. THE SLING WAS DIVIDED DUE TO TIGHTNESS AND PROXIMITY OF THE URETHRAL LUMEN. DIVISION OF SLING WAS DONE UNDER GENERAL ANESTHESIA. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448330 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC OTN BOSTON SCIENTIFIC - MARLBOROUGH UNK676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other