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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Fatigue (1849); Nausea (1970)

Event Type  Injury  

Event Description

Patient reached out to us stating they have been experiencing abdominal/gi issues.Patient does have ibs but feels issues are being brought on by aligners.Patient said they saw their gi doctor and after running tests they can only conclude it's the aligners.Patient reported 80% improvement of symptoms after they stopped treatment with the aligners.

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation.

• Brand Name: BYTE DAY ALIGNER
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): STRAIGHT SMILE, LLC; 1556 20tth st. , suite a; santa monica CA 90404
• Manufacturer (Section G): STRAIGHT SMILE, LLC; 1556 20tth st. , suite a; santa monica CA 90404
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 15277162
• MDR Text Key: 298415257
• Report Number: 3014845255-2022-00012
• 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: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other