BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER SYTLUS

    MDR report key: 11619776 · Received April 6, 2021

    Report

    Report Number
    3011625895-2021-00003
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    January 28, 2021
    Report Date
    April 6, 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 THE TREAT THE POSTERIOR NASAL NERVE REGION OF THE NASAL AIRWAY. THE PROCEDURE WAS PERFORMED BILATERALLY AND RELATIVELY UNREMARKABLY ACCORDING TO THE PHYSICIAN. THE PHYSICIAN REPORTED SOME MINOR OOZING AT THE END OF THE CASE THAT WAS CONTROLLED WITH AN EPI SOAKED COTTON PLEDGET. THE PATIENT HAD SOME SELF LIMITED OOZING THAT EVENING AND THE NEXT DAY WHICH STOPPED WITHIN 24 HOURS OF THE PROCEDURE AND DID NOT NEED ANY INTERVENTION. 14 DAYS POST-PROCEDURE, THE PATIENT CAME INTO THE OFFICE WITH SOME CONGESTION. THERE WERE CRUSTS IN BOTH NASAL PASSAGES THAT WERE REMOVED WITHOUT ANY BLEEDING AT THAT TIME. THREE WEEKS POST-PROCEDURE, THE PHYSICIAN RECEIVED A CALL FROM THE ER. THE PATIENT HAD STARTED BLEEDING SPONTANEOUSLY, OVER 100ML IN TOTAL. THE PHYSICIAN WAS UNABLE TO CONTROL THE BLEEDING AT THE BEDSIDE AND TOOK THE PATIENT TO THE OPERATING ROOM FOR RIGHT SPENOPALATINE ARTERY LIGATION. THERE WAS A SMALL ARTERIAL BLEEDER AT THE RIGHT TREATMENT SITE. THE LAST FOLLOW-UP VISIT WITH THE PATIENT OCCURRED ONE MONTH FOLLOWING THE BLEEDING EVENT. THE PATIENT HAS HEALED NOW. THERE WAS NO REPORT OF DEVICE MALFUNCTION BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522257 RHINAER SYTLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG815 UNKNOWN 08886479300184

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention