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

Model Number	FG2258
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bleeding is a known potential adverse effect releated to the use of radiofrequency energy on tissue in the nose.
Event or Problem Description
Patient experienced epistaxis approximately two weeks post-procedure.The patient went to the emergency department for care and received nasal packing.Epistaxis did not resolve with nasal packing and the patient was taken to the operating room for cauterization of the sphenopalatine artery.

• 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: michael agresto ; 2565 leghorn st.; mountain view, CA 94043 ; 7328501584
• MDR Report Key: 25337384
• Report Number: 3011625895-2026-00005
• Device Sequence Number: 9920538
• Product Code: GEI
• UDI-Device Identifier: 08886479300306
• UDI-Public: 08886479300306
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: FG2258
• Device Catalogue Number: CAT2259
• 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: 05/08/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female