BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA STRATUS MICROFLOW SPACER

    MDR report key: 3012921 · Received February 25, 2013

    Report

    Report Number
    3005172759-2013-00004
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K083574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED-UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. VP OF MEDICAL AFFAIRS CONCLUDED THAT THE FRONTAL SINUS SPACER MOST LIKELY DISLODGED BOTH FROM THE FORCE OF THE SNORTING AND THE WIDE FRONTAL RECESS FROM THE PREVIOUS SURGERY. THERE WAS NO ADVERSE EVENT EXPERIENCED BY THE PT OTHER THAN THE NEED FOR X-RAYS. THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVAL AND ITS WHEREABOUTS ARE UNK. 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

    ACCLARENT WAS NOTIFIED ON (B)(6) 2013 OF AN EVENT THAT OCCURRED ON (B)(6) 2013, DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE SURGEON PERFORMED A FRONTAL SINUS BALLOON SINUPLASTY WITH NO DIFFICULTY. AFTER THAT, HE ELECTED TO INSERT AN ACCLARENT FRONTAL SINUS SPACER BILATERALLY. HE FILLED THE SPACER WITH TRIAMINCINALONE WHICH HE KNEW WAS OFF-LABEL USE. SEVERAL DAYS LATER, THE PT SNORTED BACKWARDS AND FELT PAIN IN THE NOSE. SHE WAS CERTAIN SHE SWALLOWED THE SPACER. THE SURGEON PERFORMED AN OFFICE NASAL ENDOSCOPIC EXAM AND COULD NOT SEE THE SPACER. THE CHEST AND ABDOMINAL X-RAYS WERE OBTAINED AND THE SURGEON DISCUSSED THE EVENT WITH A GASTROENTEROLOGIST AND BOTH AGREED THAT SINCE THERE WERE NO SYMPTOMS, NOTHING MORE WOULD BE DONE. NO FURTHER REPORTED SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81052 RELIEVA STRATUS MICROFLOW SPACER STRATUS FRONTAL SPACER KAM ACCLARENT, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCLARENT BALLOON