InjuryPOW
AMARA VIEW FULL FACE MASK
Received Oct 27, 2022 · Event occurred Oct 25, 2022
Report MW5112944 · MDR key 15690704
Device
Generic name
Ventilator, Non-continuous (respirator)
Manufacturer
Phillips / Philips Electronics, Inc.Model number
Amara View Mask Without Headgear, Medium, USCatalog number
1090633
Lot number
(10)84355993
Product problems
- Patient-Device Incompatibility
Patient
65 YR · Female
- Failure of Implant
- Reaction to Medicinal Component of Device
- Failure of Implant
- Reaction to Medicinal Component of Device
Narrative
Description of Event or Problem
I HAD A DENTAL BRIDGE THAT HAD TO BE REMOVED. IT CONTAINED METAL AND I USED THE AMARA FULL FACE MASK EVERY NIGHT FOR APPROXIMATELY 5 YEARS. I AM NOW HAVING TO GET BONE GRAFTS AND DENTAL IMPLANTS FOR 5 TEETH IN THE FRONT OF MY MOUTH. IT IS GOING TO COST ME APPROXIMATELY (B)(6) AND MY DENTAL INSURANCE DOES NOT COVER IT. FDA SAFETY REPORT ID (B)(4).