MAUDE Adverse Event Report: AERIN MEDICAL INC. RHINAER STYLUS; RADIOFREQUENCY PROBE

Model Number	FG1393
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyporesponsive to stimuli (2683)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sensory changes are listed as potential adverse effect in the device labeling.
Event or Problem Description
Patient was treated with the rhinaer stylus.Six treatments were administered to the posterior nasal nerve region on each side.No complications were noted at the time of treatment.Day 5 the patient was seen in the office and was noted to have mucopurulent drainage in the middle meatus on endoscopic exam and was diagnosed with moderate acute sinusitis (unrelated to study device/procedure) and was treated with prednisone and doxycycline and endoscopic debridement of crusting.Day 93 the patient was seen in the office and was noted to have mild yellow crusting at septal deviation and mild, clear rhinorrhea, no nao and mild tissue edema on left side.Day 170 the patient had a telephone visit and reported numbness in the back of the nose making it difficult to clear mucus from the area in the morning when patient wakes up.The onset of this event was reported to be day 121.Day 353 the patient indicated the numbness had improved but not completely resolved.Day 378 the patient reported still feeling a little numbness, numbness has improved and not bothersome at this time.

• Brand Name: RHINAER STYLUS
• Common Device Name: RADIOFREQUENCY PROBE
• Manufacturer (Section D): AERIN MEDICAL INC.; 2565 leghorn st.; mountain view CA 94043
• Manufacturer (Section G): AERIN MEDICAL SINGAPORE PTE. LTD.; 60 albert street #16-01; singapore 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 19969322
• Report Number: 3011625895-2024-00006
• Device Sequence Number: 15693763
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K221907
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Device Lot Number: 10117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 64 YR
• Patient Sex: Female