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

Lot Number	2038031
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	04/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: the original email from the customer states: this patient's trays were delivered on april 23rd and she informed dr.Crawford she is having an allergic reaction to the trays.She knows it is the trays because the outbreak will disappear when they are removed.The customer has sent updated information: the answers to your questions are as follows: presence of a rash? yes.On the 4th day a rash became present on the chin and outside of mouth and her lips began to burn.Presence of sores? yes, sores are present on the inside of the mouth along the cheeks where aligners would rub.Presence of swelling? yes gums were swelling.Presence of fever? no.Difficulty breathing? patient said they had slight wheezing at night known allergy to plastic? no just latex.Any allergies to disinfectants? no.Was the product rinsed at seating? no.What was used to clean the product? she just rinsed them with water does the product appear to be clean? yes.Has the patient seen an allergist or their primary care physician? not for this specific outbreak.If the patient has been diagnoses, what were the results? what measures were taken to alleviate the reaction? patient removed the aligners and the rash went away after two days.Please include a photo of the issue.No photos were taken.Is the product being returned? yes.No changes have been made to the manufacturing process or materials that would result in potential 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 complaint pertains to a possible allergic reaction to aligner wear.On the 4th day of wear, a rash on the chin and outside the mouth appeared aloing sores inside the mouth and the sensation of burning on her lips.Slight wheezing at night was also noted.These symptoms dissipated after cessation of aligner wear.The patient reports an allergy to latex.Based on this information an allergic reaction may be possible.
Event or Problem Description
This patient's trays were delivered on april 23rd and she informed dr.(b)(6) she is having an allergic reaction to the trays.She knows it is the trays because the outbreak will disappear when they are removed.

• Brand Name: CLEARCORRECT SYSTEMS
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 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: 22029271
• Report Number: 3007130440-2025-00005
• Device Sequence Number: 8219657
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52625535035564/16D20250314
• 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: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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
• Device Lot Number: 2038031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: 43 YR
• Patient Sex: Unknown