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	04/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Nose bleeds are a known potential side effect related to the use of radiofrequency energy on the tissue in the nose.This side effect is listing in the device labeling.
Event or Problem Description
The patient was seeking treatment for nasal obstruction, chronic rhinitis, and chronic sinusitis.The patient was not on anticoagulant or antiplatelet therapy, does not have a history of hypertension or abnormal bleeding, and is a former smoker who discontinued 13 years ago.The physician performed a balloon sinuplasty, inferior turbinate reduction, vivaer, and rhinaer without complication.The physician saw the patient in his office approximately 18 days later, at which time endoscopic inspection revealed normal healing with no evidence of bleeding or scabbing in the rhinaer treatment area.Five days later, the patient experienced a nosebleed and presented at the er.The patient received bilateral nasal packing and was discharged to home.The next day the patient presented at a different er with bleeding and was found to be hypotensive and tachycardic with a low hemoglobin level.The patient was taken to the or.Endoscopic inspection of the area revealed active bleeding in the posterior middle meatus.The bleeding area was cauterized which resulted in cessation of bleeding.The patient was given a 2-unit blood transfusion.The patient was taken the icu for observation and discharged to home with a normal hemoglogin level and without further complication.The physician is closely following the patient's progress.

• 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: 19389212
• Report Number: 3011625895-2024-00002
• Device Sequence Number: 20771923
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 01/01/2025
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Device Lot Number: 33156
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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: 51 YR
• Patient Sex: Female