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

Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Subclinical Infection (2247)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clear correct findings: patient has chemical reactions and several allergies.Issue occurred in the throat and tongue.Pending additional information from the customer.Ps sent the msds to the customer so the patient can identify if anything in the material is a known allergy for her.Provider services has tried reaching out the customer, however, there has been no response.***update june 4, 2025*** https://clearcorrect.Zendesk.Com/agent/tickets/1346947 - customer called in to get the msds sheet and stated the patient did go to the er for the reaction and it was determined the devices were the cause of the issue; however, no report was received to verify the diagnosis.Clinical evaluation: the complaint is from a patient who believes she is having an allergic reaction.She also reports a history of chemical reactions and allergies.There is no clinical evaluation, medical and dental history, additional details, photographs or other information provided.Given the history of several allergies and lack of a professional opinion, no associations with the retainers or other conclusions can be determined at this time.
Event or Problem Description
Patient called to report it, she had an allergic reaction to the retainer.She has the allergic in the throat and the tongue.She wanted to know the materials the retainers are made.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT; 21 cypress blvd; suite 1010; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; suite 1010; round rock, TX 78665 ; 8883313323
• MDR Report Key: 22178064
• Report Number: 3007130440-2025-00007
• Device Sequence Number: 12633496
• Product Code: NXC
• UDI-Device Identifier: D865REF04001
• UDI-Public: +D865REF04001/$$52629236285529/16D20250421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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
• Operator of Device: Health Professional
• 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: 05/28/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 35 YR
• Patient Sex: Female