CLEARVIEW NASAL MASK
Received Nov 17, 2022
Report 2020813-2022-00007 · MDR key 15819741
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THROUGH FOLLOW-UP WITH THE USER FACILITY, ACCUTRON LEARNED THAT MORE THAN ONE PATIENT HAD ADVERSE EVENTS FROM THE CLEARVIEW NASAL MASK. THE USER FACILITY DECLINED TO PROVIDE THE NUMBER OF PATIENTS OR DATES OF THE EVENTS. IT WAS REPORTED THAT EACH PATIENT RECOVERED ON THEIR OWN WITH NO MEDICAL TREATMENT BEING SOUGHT OR ADMINISTERED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.
Additional Manufacturer Narrative
ACCUTRON HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE CURRENT PATIENT STATUS. TO DATE, WE HAVE NOT RECEIVED A RESPONSE WITH ADDITIONAL INFORMATION. THE USER FACILITY WAS PROVIDED WITH A COPY OF THE INSTRUCTIONS FOR USE FOR THE CLEARVIEW NASAL MASK AND CLEARVIEW SCAVENGING CIRCUIT AS REQUESTED. 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 FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED ADVERSE EFFECTS AFTER USING A CLEARVIEW NASAL MASK DURING A DENTAL PROCEDURE.