MAUDE Adverse Event Report: BRIUS TECHNOLOGIES BRIUS BRAVA SYSTEM; WIRE, ORTHODONTIC

Model Number BRAVA

Device Problem Biocompatibility (2886)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/08/2022

Event Type  Injury  

Event Description

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.

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.

• Brand Name: BRIUS BRAVA SYSTEM
• Type of Device: WIRE, ORTHODONTIC
• Manufacturer (Section D): BRIUS TECHNOLOGIES; 2611 westgrove dr ste 109; carrollton,; carrollton, TX 75006
• Manufacturer (Section G): BRIUS TECHNOLOGIES
• Manufacturer Contact: fariba khajouei ; 2611 westgrove drive; suite 109; carrollton, TX 75006 ; 2345643134
• MDR Report Key: 15566620
• MDR Text Key: 301477406
• Report Number: 3014680924-2022-00004
• Device Sequence Number: 1
• Product Code: DZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BRAVA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White