MAUDE Adverse Event Report: SWIFT HEALTH SYSTEMS INBRACE TEETH STRAIGTHENING SYSTEM; ORTHODONTIC APPLIANCE

Model Number 8101

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

Patient symptoms of itchy mouth appear to be symptoms of an allergic reaction to the orthodontic appliance.The symptoms subsided with the use of antihistamines.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 these metals.

Event Description

It was alleged that a patient had an allergic reaction to the inbrace orthodontic appliance system.The patient reported that her whole mouth was itchy and the symptoms subsided with antihistamines.The patient requested removal of her braces.

• Brand Name: INBRACE TEETH STRAIGTHENING SYSTEM
• Type of Device: ORTHODONTIC APPLIANCE
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS; 111 academy. suite 150; irvine CA 92617
• Manufacturer Contact: alicia mszyca ; 111 academy, suite 150; irvine, CA 92617 ; 9497742239
• MDR Report Key: 13159708
• MDR Text Key: 286650315
• Report Number: 3013023655-2022-00001
• Device Sequence Number: 1
• Product Code: DZC
• UDI-Device Identifier: 00850018135009
• UDI-Public: (01)00850018135009(10)WO125600(11)211015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 01/04/2022

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 Operator: Health Professional
• Device Model Number: 8101
• Device Catalogue Number: 8101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female