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	08/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Prior to treatment with the rhinaer stylus, both topical and injectable local anesthesia were administered.Patient was then treated with the rhinaer stylus.Physician treated 6-9 locations on each side in the posterior nasal nerve regionco, then treated a couple on each inferior turbinate.The posterior edge of the inferior turbinate was the most posterior treatment site.No other procedures were performed.Eighteen days post-procedure the patient experienced a nosebleed and called the treating physician's office.The physician at the office instructed the patient to hold pressure on their nose to help stop the bleed.The bleeding did not stop.The patient went to the er, was packed and discharged.The patient was uncomfortable being discharged and went to a different er and was admitted.The duration of the hospitalization at the second hospital is unknown at this time.The exact location of the bleeding is unknown.The treating ent was not present when the patient presented to the er.
Additional Manufacturer Narrative
None.

• 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: 20220082
• Report Number: 3011625895-2024-00009
• Device Sequence Number: 20808457
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/14/2024

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 Model Number: FG1393
• Device Catalogue Number: CAT1394
• 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: 08/15/2024
• Initial Report FDA Received Date: 09/14/2024
• 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: Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Female