PIP+ NASAL MASK
Report
- Report Number
- 2020813-2021-00001
- Event Type
- Malfunction
- Date Received
- December 20, 2021
- Date of Event
- December 6, 2021
- Report Date
- December 20, 2021
- Manufacturer
- ACCUTRON, INC.
- Product Code
- KHA
- PMA / PMN Number
- K970046
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DETAILS OF THE PRODUCT SUBJECT OF THE EVENT ARE NOT AVAILABLE AS THE REPORTED PRODUCT WAS DISCARDED AND NOT RETURNED FOR EVALUATION. THE REPORTED PRODUCT IS INDICATED FOR SINGLE USE. THE CUSTOMER CONFIRMED THAT A NEW NASAL MASK IS USED FOR EACH PATIENT AND THAT THERE WERE NO VISUAL DAMAGES OR DEFECTS NOTED PRIOR TO USE OF THE REPORTED NASAL MASK. THE FOLLOWING LANGUAGE RELATED TO PRODUCT BIOCOMPATIBILITY AND CONSTRUCTION CAN BE FOUND IN THE ACCUTRON PIP+ NASAL MASK IFU (28743, REV E) PROVIDES THE FOLLOWING RELEVANT LANGUAGE, "NOT MADE WITH NATURAL LATEX RUBBER. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED." THE ACCUTRON PIP+ NASAL MASK PERFORMED AS INTENDED. IN A REVIEW OF COMPLAINTS OVER THE LAST 2 YEARS, THERE HAVE BEEN NO REPORTS RECEIVED FOR SIMILAR EVENTS. ACCUTRON WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.
THE DETAILS OF THE PRODUCT SUBJECT OF THE EVENT ARE NOT AVAILABLE AS THE REPORTED PRODUCT WAS DISCARDED AND NOT RETURNED FOR EVALUATION. THE REPORTED PRODUCT IS INDICATED FOR SINGLE USE. THE CUSTOMER CONFIRMED THAT A NEW NASAL MASK IS USED FOR EACH PATIENT AND THAT THERE WERE NO VISUAL DAMAGES OR DEFECTS NOTED PRIOR TO USE OF THE REPORTED NASAL MASK. THE FOLLOWING LANGUAGE RELATED TO PRODUCT BIOCOMPATIBILITY AND CONSTRUCTION CAN BE FOUND IN THE ACCUTRON PIP+ NASAL MASK IFU (28743, REV E) PROVIDES THE FOLLOWING RELEVANT LANGUAGE, "NOT MADE WITH NATURAL LATEX RUBBER. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED." THE ACCUTRON PIP+ NASAL MASK PERFORMED AS INTENDED. IN A REVIEW OF COMPLAINTS OVER THE LAST 2 YEARS, THERE HAVE BEEN NO REPORTS RECEIVED FOR SIMILAR EVENTS. ACCUTRON WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.
THE USER FACILITY REPORTED THAT 15 MINUTES INTO THE SCHEDULED PROCEDURE USING AN ACCUTRON PIP+ NASAL MASK, A PATIENT DEVELOPED A SWOLLEN UPPER LIP AND REDNESS OF THE NOSE AND CHEEK AREA. THE PROCEDURE WAS STOPPED, THE NASAL MASK WAS REMOVED AND THE PATIENT RECEIVED ORAL BENADRYL. THE PATIENT'S SYMPTOMS IMPROVED AND THE SCHEDULED PROCEDURE WAS ABLE TO BE COMPLETED. DURING A ROUTINE FOLLOW-UP SEVERAL DAYS AFTER THE REPORTED EVENT, IT WAS CONFIRMED THAT ALL OF THE PATIENT SYMPTOMS HAD BEEN RESOLVED. NO ADDITIONAL REPORTS OF ADVERSE EVENT WERE RECEIVED FOR THIS PRODUCT.
THE USER FACILITY REPORTED THAT 15 MINUTES INTO THE SCHEDULED PROCEDURE USING AN ACCUTRON PIP+ NASAL MASK, A PATIENT DEVELOPED A SWOLLEN UPPER LIP AND REDNESS OF THE NOSE AND CHEEK AREA. THE PROCEDURE WAS STOPPED, THE NASAL MASK WAS REMOVED AND THE PATIENT RECEIVED ORAL BENADRYL. THE PATIENT'S SYMPTOMS IMPROVED AND THE SCHEDULED PROCEDURE WAS ABLE TO BE COMPLETED. DURING A ROUTINE FOLLOW-UP SEVERAL DAYS AFTER THE REPORTED EVENT, IT WAS CONFIRMED THAT ALL OF THE PATIENT SYMPTOMS HAD BEEN RESOLVED. NO ADDITIONAL REPORTS OF ADVERSE EVENT WERE RECEIVED FOR THIS PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1941087 | PIP+ NASAL MASK | UNIVERSAL LOW PROFILE NASAL HOODS | KHA | ACCUTRON, INC. | 33016-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |