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	Epistaxis (4458)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was treated bilaterally with rhinaer stylus in the office under local anesthesia.The patient presented to the office 5 days post-procedure with brisk bleeding that was not able to be controlled in the office setting.The patient was taken to the or where a bleed from a branch of the right spa was controlled with cautery.The patient had vomited a large amount of blood and for safety was intubated and kept in the icu overnight.The patient required transfusion of prbcs (packed red blood cells) and ffp (fresh frozen plasma).The next day the patient was stable, extubated and sent home.The patient had another brisk, but not as severe, bleed 4 days later (9 days post-procedure) from the left side.The patient was packed in the ed to temporarily control the bleed, then taken to the or where the bleed, near the attachment of the left middle turbinate, was controlled with cautery.A small, less significant bleed on the right, in a different spot than previously treated, was also cauterized.The patient was kept overnight, did well and then was sent home.The patient followed up 14 days post-procedure and was doing well.

• 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 INC.; 2565 leghorn st.; mountain view CA 94043
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 22040092
• Report Number: 3011625895-2025-00006
• Device Sequence Number: 9095218
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: (01)08886479300238(17)270101(10)39267
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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 Model Number: FG1393
• Device Catalogue Number: CAT1394
• Device Lot Number: 39267
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2025
• 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: Other; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male