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	09/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent rhinaer and presented at the emergency room two weeks later with nasal bleeding.The patient received packing at the er and was then transported to a surgical facility.The patient underwent ligation of the bleeding artery on one side, which stopped the bleeding.The patient received a transfusion at that time due to hemoglobin falling to 8.The patient is now 5-6 weeks out and doing well.The patient was not on any anticoagulation therapy.
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: 20554611
• Report Number: 3011625895-2024-00012
• Device Sequence Number: 18387379
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/29/2024

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: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• 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: Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White