BRIUS BRAVA SYSTEM
Received Oct 7, 2022 · Event occurred Sep 8, 2022
Report 3014680924-2022-00004 · MDR key 15566620
Device
Product problems
- Biocompatibility
- Biocompatibility
Patient
37 YR · Female
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
THE DOCTOR REPORTED BURNING SENSATION AND NUMBNESS IN THE MOUTH AND LIPS OF THE PATIENT, SUSPECTING OF AN ALLERGIC REACTION TO THE BRAVA APPLIANCE. THE LABELING OF THE DEVICE WARNS THAT THE PRODUCT CONTAINS NICKEL AND CHROMIUM AND SHOULD NOT BE USED FOR INDIVIDUALS WITH KNOWN ALLERGIC SENSITIVITY TO THOSE METALS. BRAVA SYSTEM WAS REMOVED AFTER 4 WEEKS.
Additional Manufacturer Narrative
THE DOCTOR REPORTED BURNING SENSATION AND NUMBNESS IN THE MOUTH AND LIPS OF THE PATIENT, SUSPECTING OF AN ALLERGIC REACTION TO THE BRAVA APPLIANCE. THE LABELING OF THE DEVICE WARNS THAT THE PRODUCT CONTAINS NICKEL AND CHROMIUM AND SHOULD NOT BE USED FOR INDIVIDUALS WITH KNOWN ALLERGIC SENSITIVITY TO THOSE METALS. BRAVA SYSTEM WAS REMOVED AFTER 4 WEEKS.