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 Codes	Bacterial Infection (1735); Fungal Infection (2419); Epistaxis (4458)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician performed an uneventful rhinaer procedure on a patient in his office.He injected local with a spinal needle and there was some bleeding on the left side in the posterior region.The bleeding was easily stopped and the procedure continued.The patient went home and experienced some mild bleeding three days later but was able to control it at home.The next day the patient continued to bleed and presented to the physician's office and was packed.The following day the patient bled again, through the packing, and was sent to the ed where the bleeding temporarily stopped.That evening the patient was taken to the or where the source of bleeding was found in the left posterior left region.Of note, the mucosa was significantly swollen.Phenylephrine pledgets were applied and the bleed was controlled with cautery.Txa was given.The patient did well and has had no further bleeding to date.At 2.5 weeks post procedure, the patient followed up and crusting was noted.The patient was instructed to continue with nasal irrigations.At 7 weeks post procedure, the patient followed up and significant crusting as well as bilateral purulence was seen.A culture was taken and antibiotics were started and later switched to levaquin per the culture results.At 11 weeks post procedure, the patient followed-up and had significant crusting remaining.A culture was taken that revealed mold on the left.The patient started gentamicin nasal rinses.Another follow up revealed no change and was sent to an infectious disease consult.Id recommended anti-fungal rinses.Amphotericin douches were going to be started.The patient does not appear to have any unusual work or volunteer conditions that would make them susceptible to infections.The patient takes ofev (nintedanib) which is used to treat idiopathic pulmonary fibrosis.No known autoimmune disease or pmh that would place the patient in an immunocompromised state.The physician followed up with his patient around 15 weeks post procedure and reported that the patient was doing much better.No crusting reported, some inflammation.The physician is not concerned at this time.The patient continues to have a chronic cough and reported to physican they have idiopathic pulmonary fibrosis.The patient went to see the physician who treats this and was started on prednisone over the same time frame as the nasal rinses.
Additional Manufacturer Narrative
Risk of serious delayed bleeding identified in device labeling.

• 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: 21580349
• Report Number: 3011625895-2025-00003
• Device Sequence Number: 8867909
• Product Code: GEI
• UDI-Device Identifier: 08886479300238
• UDI-Public: 08886479300238
• Combination Product (Y/N): N
• 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): 03/11/2025

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: 02/10/2025
• Initial Report FDA Received Date: 03/11/2025
• 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: Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Female