MAUDE Adverse Event Report: NASA TOUCH ATOMIZER

Device Problem Insufficient Information (3190)

Patient Problems Twitching (2172); No Code Available (3191)

Event Date 02/08/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 i was given a prescription of tobramycin and betamethasone with a nasa touch atomizer to treat a chronic sinus infection.After using these for two weeks, i lost all sense of smell and my left eye began to twitch.Two weeks prior to using the medication, i had sinus surgery to open up the cavities.As soon as i noticed the loss of smell, i stopped using the medications and the atomizer.I reported this to my doctor (b)(6) who said he did not believe the medication or the atomizer had caused this issue and that i should continue to use them.My sense of smell did not return for over a year.I gradually began to smell after a year had passed and even then it was intermittent.Dose or amount: 1 vial.Frequency: twice daily.Route: inhalation.Dates of use: (b)(6) 2014.Reason for use: to relieve chronic sinusitis.

• Brand Name: NASA TOUCH ATOMIZER
• Type of Device: NASA TOUCH ATOMIZER
• MDR Report Key: 5541610
• MDR Text Key: 41820090
• Report Number: MW5061421
• Device Sequence Number: 1
• Product Code: CAF
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 102