CLEARVIEW NASAL MASK
Received Aug 25, 2022
Report 2020813-2022-00005 · MDR key 15298479
Device
Generic name
Mask
Manufacturer
Accutron, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF CLEARVIEW NASAL MASK, THE PATIENT DEVELOPED REDNESS OF THE FACE. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.
Additional Manufacturer Narrative
THE REPORTED PRODUCT IS INDICATED FOR SINGLE USE. THE CLEARVIEW NASAL MASK INSTRUCTIONS FOR USE STATES, "WARNINGS: TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE, USING TITRATION METHOD. PATIENT SHOULD ALWAYS BE CLOSELY MONITORED DURING NITROUS OXIDE USE. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED." A 2-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.