MAUDE Adverse Event Report: CLEARCORRECT CLEARCORRECT SYSTEM; CLEAR PLASTIC ORTHODONTIC ALIGNER

Lot Number	1688907
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: the phase 1 was manufactured on april 24, 2024.A review of the manufacturing ledger shows no issues.The patient stated the incident occurred on may 14, 2024.The symptoms appeared immediately upon wearing the first step.The patient removed the devices, and stated the symptoms subsided.The patient tried again the following date and stated the symptoms reappeared.The patient stated she visited a doctor, but no report or diagnosis was provided.There was no presence of rash, fever, or difficulty breathing.The device was rinsed before use.The patient was unaware of any allergies to plastic or disinfectants but stated it was possible.Photos and diagnosis have been requested.There have been no changes to the manufacturing process or materials during the time of production.No contributing factors were determined that would result in adverse reactions.Allergic reactions are a documented undesired side-effect of clear aligner therapy which are closely monitored via post-market surveillance.The trending data shows no negative impacts to risk/benefit, and the occurrence rate is within the expected range.Clinical evaluation: the report is of high blood pressure, tingling in the hands and feet, sores on the tongue and swelling of the lips and face immediately upon insertion of the first aligner step.The aligners were removed and the following day another reinsertion was attempted with the same result.A subsequent visit to a physician did not reveal a diagnosis or any other suggestions.The following day another attempt to wear the aligners was tred with the same resultanat symptoms.No photographs or clinical examination information was provided.With the limited information provided it is not possible to determine a clear cause for the symptoms however it is also not possible to rule out potential allergy and the etiology remains indeterminate.
Event or Problem Description
(b)(6) from the provider's office contacted customer care and reported the patient experienced a potential allergic reaction.Patient reported they had high blood pressure, tingling in the hands and feet, sores on their tongue and swelling on the lips and face.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; round rock, TX 78665
• MDR Report Key: 19605651
• Report Number: 3007130440-2024-00005
• Device Sequence Number: 15498409
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52529726489621/16D20240424
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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 Expiration Date: 10/24/2024
• Device Lot Number: 1688907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female