BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVAER STYLUS

    MDR report key: 15307612 · Received August 26, 2022

    Report

    Report Number
    3011625895-2022-00004
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    July 22, 2022
    Report Date
    August 26, 2022
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300160
    PMA / PMN Number
    K200300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETERIORATION OF MUCOSA PROBABLY EXACERBATED WITH USE OF TOPICAL NASAL DECONGESTANT SPRAY. TOPICAL NASAL DECONGESTANT SPRAYS HAVE BEEN REPORTED TO CAUSE MUCOSAL PERFORATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE PATIENT WAS TREATED WITH THE VIVAER STYLUS ONLY ON THE RIGHT SIDE. THE SWELL BODY, INTERNAL NASAL VALVE AND THE INFERIOR TURBINATE WERE TREATED. PATIENT HAD FIRST FOLLOW UP VISIT ON (B)(6) 2022 AND AGAIN ON (B)(6) 2022. AT BOTH VISITS, THE PATIENT SHOWED GOOD MUCOSAL HEALING. AT THIRD FOLLOW-UP VISIT ON (B)(6) 2022, MUSCOSA WAS INTACT. PHYSICIAN DISCUSSED SEPTO-TURB OPTION WITH THE PATIENT BECAUSE PATIENT WAS STILL COMPLAINING OF CONGESTION. AT 7-MONTH FOLLOW-UP ON (B)(6) 2022, PATIENT PRESENTED WITH CRUSTING ON SEPTUM AND 1X1 CM2 MUCOSAL PERFORATION IN AREA TREATED WITH VIVAER STYLUS. CARTILAGE WAS INTACT. THE PATIENT REPORTED USING AFRIN OFF AND ON FOR PAST MONTH. PHYSICIAN PLANS TO MOVE FORWARD WITH SEPTOPLASTY PROCEDURE TO ADDRESS PERSISTENT CONGESTION. TOPICAL NASAL DECONGESTANT SPRAYS HAVE BEEN REPORTED TO CAUSE MUCOSAL PERFORATION. THE DETERIORATION OF THE MUCOSA IS PROBABLY RELATED TO THE COMBINATION OF THE RADIOFREQUENCY TREATMENT OF THE TISSUE IN THE AREA FOLLOWED BY USE OF AFRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088006 VIVAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG722 08886479300160

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other