BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX II SYSTEM

    MDR report key: 3790121 · Received May 5, 2014

    Report

    Report Number
    3005099803-2014-01828
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K121754
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND 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 II, HALO DEVICE WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE SUBJECT EXPERIENCED PAIN IN THE VAGINAL/ABDOMINAL AREA THAT WAS MODERATE IN SEVERITY AND HAS NOT YET RESOLVED. THE SUBJECT TOOK OXYCODONE AND TYLENOL FOR THE PAIN. ON (B)(6) 2014, THE PATIENT ALSO EXPERIENCED CONSTIPATION THAT WAS MILD IN SEVERITY AND RESOLVED ON THAT SAME DAY. THE INVESTIGATOR ASSESSED BOTH EVENTS AS RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX II, HALO DEVICE WAS IMPLANTED INTO THE PATIENT ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014 THE SUBJECT EXPERIENCED PAIN IN THE VAGINAL/ABDOMINAL AREA THAT WAS MODERATE IN SEVERITY AND HAS NOT YET RESOLVED. THE SUBJECT TOOK OXYCODONE AND TYLENOL FOR THE PAIN. ON (B)(6) 2014 THE PATIENT ALSO EXPERIENCED CONSTIPATION THAT WAS MILD IN SEVERITY AND RESOLVED ON THAT SAME DAY. THE INVESTIGATOR ASSESSED BOTH EVENTS AS RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED ON JUNE 9, 2014: THE PAIN RESOLVED ON (B)(6) 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266974 OBTRYX II SYSTEM MESH, SURGICAL, SYNTHETIC OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068505110 ML00001605

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention