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

Model Number FG1393

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Epistaxis (4458)

Event Date 02/05/2023

Event Type  Injury  

Manufacturer Narrative

Bleeding is 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.

Event Description

On (b)(6) 2023, patient underwent surgical procedure including septo/nasal valve lateral crural strut graft and treatment with rhinaer stylus on right and left side.No device performance issues were reported.Patient presented to the er with a left posterior nasal hemorrhage three weeks post-procedure at the treatment site.The patient was discharged.Hemoglobin level was 12.Two days later, patient presented to er again with bleeding and was taken to the operating room.Treatment with bovie and flowseal were applied to stop the bleeding.The patient was held overnight.Hemoglobin level was 9.Two days later the patient received a blood transfusion.Hemoglobin level was 7.At two months post-procedure, patient is reported to be healed and stable.

• Brand Name: RHINAER STYLUS
• Type of Device: 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: 16705220
• MDR Text Key: 312940720
• Report Number: 3011625895-2023-00002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG1393
• Device Catalogue Number: CAT1394
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization