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	Perforation (2001)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Deterioration of mucosa probably exacerbated with use of topical nasal decongestant spray.Topical nasal decongestant sprays have been reported to cause mucosal perforation.
Event or Problem Description
On (b)(6) 2022, the patient was treated with the vivaer stylus only on the right side.The swell body, internal nasal valve and the inferior turbinate were treated.Patient had first follow up visit on (b)(6) 2022 and again on (b)(6) 2022.At both visits, the patient showed good mucosal healing.At third follow-up visit on (b)(6) 2022, muscosa was intact.Physician discussed septo-turb option with the patient because patient was still complaining of congestion.At 7-month follow-up on (b)(6) 2022, patient presented with crusting on septum and 1x1 cm2 mucosal perforation in area treated with vivaer stylus.Cartilage was intact.The patient reported using afrin off and on for past month.Physician plans to move forward with septoplasty procedure to address persistent congestion.Topical nasal decongestant sprays have been reported to cause mucosal perforation.The deterioration of the mucosa is probably related to the combination of the radiofrequency treatment of the tissue in the area followed by use of afrin.

• 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 18996 9; SN 189969
• Manufacturer Contact: shannon scott ; 2565 leghorn st.; mountain view, CA 94043 ; 5122219956
• MDR Report Key: 15307612
• Report Number: 3011625895-2022-00004
• Device Sequence Number: 6360840
• Product Code: GEI
• UDI-Device Identifier: 08886479300160
• UDI-Public: 08886479300160
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/26/2022
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male