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

Lot Number	669759
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	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
"patient presents an allergic reaction.What is the current step and arch being discussed? both.· presence of a rash? itchy.· presence of sores? no.· presence of swelling? yes.· presence of fever? no.· difficulty breathing? no.· known allergy to plastic? no.· any allergies to disinfectants? no.· was the product rinsed at seating? water.· what was used to clean the product? water.· does the product appear to be clean? no.· has the patient seen an allergist or their primary care physician? no.· if the patient has been diagnoses, what were the results? bees.· what measure were taken to alleviate the reaction? stopped wearing it, tylenol.· include a photo of the issue.· is the product being returned? no.".
Additional Manufacturer Narrative
Clearcorrect findings: a review of case #(b)(4) shows the patient started treatment in (b)(6) of 2021.The patient has not experienced any issues with the devices prior to phase 5, the most recent phase received by the customer on (b)(6) 2024.Patient has discontinued use of the devices.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.Information provided by the customer: what is the current step and arch being discussed? both.· presence of a rash? itchy.· presence of sores? no.· presence of swelling? yes.· presence of fever? no.· difficulty breathing? no.· known allergy to plastic? no.· any allergies to disinfectants? no.· was the product rinsed at seating? water.· what was used to clean the product? water.· does the product appear to be clean? no.· has the patient seen an allergist or their primary care physician? no.· if the patient has been diagnoses, what were the results? bees.· what measure were taken to alleviate the reaction? stopped wearing it, tylenol.· include a photo of the issue.· is the product being returned? no.Clinical evaluation: the complaint is of itchiness and swelling, however it is not clear where this sensation was located or even if it was intraoral.No photographs were provided.The medical history shows the patient was diagnosed with an allergy to bees.At this time, aligner wear has been discontinued and the sensation alleviated but the patient has not been referred to a physician for evaluation.With the little information provided there it is no cause and effect relationship can be established.Further evaluation and documentation are warranted.

• 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: 21855083
• Report Number: 3007130440-2025-00004
• Device Sequence Number: 11941880
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52522124437974/16D20240209
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/10/2025

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
• Device Expiration Date: 08/09/2025
• Device Lot Number: 669759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown