MAUDE Adverse Event Report: AERIN MEDICAL INC. VIVAER STYLUS; RADIOFREQUENCY PROBE

Model Number	FG722
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	12/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient received vivaer treatment of the inferior turbinates and swell bodies on (b)(6) 2023.Approximately 1 month post treatment ((b)(6) 2023) the patient experienced a severe nosebleed and went to the emergency room and had embolism of the spa done to stop the bleeding and spent 5 days in the hospital.The patient reported that they lost nearly 2 pints of blood and that she was recovering but in pain and their throat was irritated from the intubation tube.Approximately 1 week later, the patient experienced a second nosebleed and returned to the emergency room.A cerebral angiogram was performed, and the patient had embolization of the spa repeated to stop the bleeding.The patient is recovering.
Additional Manufacturer Narrative
Nose bleeds are a known potential side effect related to the use of radiofrequency energy on tissue in the nose.This side effect is listed in the device labeling.

• Brand Name: VIVAER 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 189969, sgp 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043
• MDR Report Key: 18490156
• Report Number: 3011625895-2024-00001
• Device Sequence Number: 17027711
• Product Code: GEI
• UDI-Device Identifier: 08886479300160
• UDI-Public: 08886479300160
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: FG722
• Device Catalogue Number: CAT723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female