BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 2703747 · Received August 6, 2012

    Report

    Report Number
    3005172759-2012-00028
    Event Type
    Other
    Date Received
    August 6, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 17, 2012
    Manufacturer
    ACCLARENT INC
    Product Code
    KAM
    PMA / PMN Number
    K083574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. THE REFERRING PHYSICIAN DID NOT RECALL PLACING THE STRATUS AND THE PATIENT AND HIS FAMILY WERE NOT TOLD THE STRATUS IMPLANT WAS USED. THE IMPLANTED STRATUS SPACER WAS REMOVED SUCCESSFULLY AND THE DEVICE WAS INTACT. THE ACCLARENT STRATUS DEVICES ARE APPROVED FOR IMPLANTATION FOR A 14 DAYS PERIOD. WHILE THE ACCLARENT STRATUS DEVICE WAS LEFT IN PLACE FAR BEYOND THE 14 DAYS INDICATION, THERE WAS NO INJURY TO THE PATIENT AND NO ADDITIONAL CARE BECAUSE OF RETAINED STRATUS DEVICE. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. NO OTHER DEVICES WERE RETURNED FOR EVALUATION FROM THE USER FACILITY. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT IN REVIEWING THE CT SCAN OF THE PATIENT, SHE FOUND THE PATIENT HAD ACCLARENT STRATUS SPACER IMPLANTED IN THE FRONTAL RECESS FOR AN UNKNOWN DURATION. THE SURGEON DECIDED TO DISSECT AND REMOVE THE STRATUS. ACCLARENT WAS INFORMED THAT THE PATIENT IS DOING WELL REPORTED DID WELL AND NO ADDITIONAL CARE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA STRATUS MICROFLOW SPACER STRATUS FRONTAL SPACER KAM ACCLARENT INC BC1417RS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention