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)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient had a rhinaer procedure.Three weeks post-procedure she experienced severe bleeding from the nose.The patient presented to the emergency room and received a sphenopalatine artery ligation.
Additional Manufacturer Narrative
Bleeding is a known potential adverse effect related to the use of radiofrequency eneregy on tissue in the nose.

• 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 ; +1(732)850-1584
• MDR Report Key: 50819935
• Report Number: 3011625895-2026-00009
• Device Sequence Number: 10713094
• Product Code: GEI
• UDI-Device Identifier: 08886479300306
• UDI-Public: 08886479300306
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 82 YR
• Patient Sex: Female