MAUDE Adverse Event Report: STRAIGHT SMILE, LLC BYTE AT NIGHT ALIGNER SYSTEM; ALIGNER, SEQUENTIAL

Catalog Number NBYTESYSTEM

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Sore Throat (2396); Swelling/ Edema (4577)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a patient experienced a potential allergic reaction after developing extreme sore throat, headache, nausea and swollen tongue.Patient plans to seek medical consultation to determine root cause.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: BYTE AT NIGHT ALIGNER SYSTEM
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE, LLC; 1556 20tth st. , suite a; santa monica CA 90404
• MDR Report Key: 11611729
• MDR Text Key: 243723606
• Report Number: 3014845255-2021-00001
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• PMA/PMN Number: K180346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: NBYTESYSTEM
• Date Manufacturer Received: 03/03/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other