BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 12170971 · Received July 14, 2021

    Report

    Report Number
    3011625895-2021-00004
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    June 13, 2021
    Report Date
    July 14, 2021
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    UDI-DI
    08886479300184
    PMA / PMN Number
    K192471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT AND DOCUMENTED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    THE RHINAER STYLUS WAS USED TO TREAT THE POSTERIOR NASAL NERVE REGION OF THE NASAL AIRWAY. BOTH RIGHT AND LEFT SIDE WERE TREATED. FIVE DAYS POST-PROCEDURE, THE PATIENT WENT TO THE ER DUE TO BLEEDING. BLEEDING WAS ON THE LEFT SIDE OF NOSE, POSTERIOR ASPECT. BLEEDING WAS CONTROLLED WITH A LATEX BALLOON. THE PHYSICIAN SAW THE PATIENT THE DAY AFTER THE BLEEDING EVENT AND THE NEXT DAY. PATIENT IS DOING WELL. THERE WAS NO REPORT OF DEVICE MALFUNCTION BY THE CLINIC. PHYSICIAN REPORTED ON 07/13/2021 THAT SHE HAD SEEN THE PATIENT AGAIN AND THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061509 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG815 10005 08886479300184

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention