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

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

Since this event resulted in a serious injury, it is reportable per 21 cfr part 803.

Event Description

While using a byte night aligner, patient experienced allergic reaction.Their symptoms consist of red marks on lips and bumps.They are itchy everywhere the aligners touch gums, teeth, tongue, sharp pains in their teeth, and they have trouble sleeping.Patient advised to seek medical attention to have this evaluated and cease use of aligners and whitening product.Aligner treatment stopped.

Manufacturer Narrative

Additional information received: letter received from patient's dentist stating: patient came inot the office on (b)(6), 2024.Patient's chief complaint is pain and possible allergic reaction dueto the u se of clear aligners and whitening products by byte.It is recommended that the patient stop the use of the products and focus on oral hygiene and completing current treatment plan within our office.

• Brand Name: BYTE NIGHT ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE , LLC; 1556 20th st. , suite a; santa monica CA 90404
• Manufacturer (Section G): STRAIGHT SMILE , LLC; 1556 20th st. , suite a; santa monica CA 90404
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 18623204
• MDR Text Key: 334327056
• Report Number: 3014845255-2024-00010
• Device Sequence Number: 1
• Product Code: NXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention