MAUDE Adverse Event Report: AERIN MEDICAL INC VIVAER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Collapse (1099)

Patient Problems Dyspnea (1816); Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Pain (1994); Scar Tissue (2060); Suffocation (2088); Burning Sensation (2146); Discomfort (2330); Numbness (2415); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/21/2020

Event Type  Injury  

Event Description

I underwent treatment with vivaer on (b)(6) 2020 because i was told i had nasal valve collapse.I was told that the device was safe, non-invasive, and had no side effects, but my breathing has not been improved and i feel worse than before i received the treatment.It has been four months since my treatment, and i have breathing difficulties, dry sinuses, and distributed pain and discomfort throughout my face, sinuses, and airway.I have been forced to use the cholinergic medication evoxac to increase mucus production and to run a humidifier 24/7 in addition to inserting various sprays and oils into my sinus cavity in order to mitigate my symptoms.Some of my symptoms include the following, ranging from intermittent to constant: cold insensitivity.Breathing in cold, dry air is painful.I believe this is because incoming air is no longer warmed or humidified, which causes a burning sensation in my airways.Burning pain in my mouth behind my front teeth and on the tongue, at the back of my throat and into my lungs, deep within my inner ears, and inside my nose, especially near the bridge.A numb sensation deep in my sinus cavity, as though it's completely empty.Extreme dryness/lack of natural mucus production.The occasional sensation of breathlessness/suffocation even though i'm breathing normally.Dry cough.Feeling of a foreign body sensation in my nostrils.My surgeon identified some scar tissue, but said otherwise that everything looks normal.I am now seeing other ent/rhinology doctors in order to identify the problem.I feel fatigued, possibly from the depression of my inflicted condition and possibly as a complication related to the breathlessness symptom.Though i am still technically functional and can work, daily activity is far more difficult and exhausting now than it was before the surgery.I feel as though i have been maimed and ruined as a result of treatment with vivaer.Fda safety report id # (b)(4).

• Brand Name: VIVAER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AERIN MEDICAL INC
• MDR Report Key: 11372356
• MDR Text Key: 233513478
• Report Number: MW5099589
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/21/2021

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 31 YR
• Patient Weight: 61