BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHINAER STYLUS

    MDR report key: 19431319 · Received May 30, 2024

    Report

    Report Number
    3011625895-2024-00003
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    March 31, 2023
    Report Date
    May 30, 2024
    Manufacturer
    AERIN MEDICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K221907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOSE BLEEDS ARE A KNOWN POTENTIAL SIDE EFFECT RELATED TO THE USE OF RADIOFREQUENCY ENERGY ON THE TISSUE IN THE NOSE. IT IS LISTED IN THE DEVICE LABELING AS A POTENTIAL ADVERSE EFFECT.

    Description of Event or Problem · 0

    PATIENT WAS TREATED WITH RHINAER STYLUS WITHOUT COMPLICATION. PATIENT WAS SEEN BY THE TREATING ENT PHYSICIAN FOR FOLLOW-UP AROUND 8 WEEKS POST PROCEDURE AND REPORTED HAVING HAD A NOSEBLEED. THE PATIENT REPORTED GOING TO THE ER FOR TREATMENT, REQUIRING MULTIPLE TRANSFUSIONS AND WAS IN THE HOSPITAL FOR 10 DAYS. THE TREATING ENT PHYSICIAN WAS NOT NOTIFIED OF THE EVENT AT THE TIME IT OCCURRED. INITIALLY THE PHYSICIAN THOUGHT THE EVENT WAS UNRELATED AND THEREFORE DID NOT IMMEDIATELY REPORT THE EVENT TO AERIN. DATE OF EVENT HAS BEEN ESTIMATED BASED ON AVAILABLE INFORMATION, APPROXIMATE TREATMENT DATE AND TIMING OF FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308728 RHINAER STYLUS RADIOFREQUENCY PROBE GEI AERIN MEDICAL INC. FG1393 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O