MAUDE Adverse Event Report: STRAIGHT SMILE , LLC BYTE DAY 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 day aligner, patient experienced an allergic reaction to the wearing of the aligners.They had irritation within 24 hours of use.After sleeping with the aligners, they noticed the gums around their teeth were bleeding and inflamed.Patient reports stopping the aligner treatment when the irritation and reaction got severe.They report that it took approximately 4 days after stopping the aligners to get the reaction to subside to a comfortable level.Then 8-9 days to have their mouth and gums back to the level of being healed.

• Brand Name: BYTE DAY 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: 18114772
• MDR Text Key: 327871756
• Report Number: 3014845255-2023-00103
• 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
• Report Date: 11/10/2023

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: 10/29/2023
• Initial Date FDA Received: 11/10/2023
• 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