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

Model Number	Aligner (Multi-layer)
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	06/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated: the patient started her trays about two weeks ago and she has been having severe reactions to it.The customer told the patient to stop treatment, and the patient is feeling better.Patient would like to cancel the treatment because it's affecting her work and sleep.Patient was on step 1 of treatment when the issue was detected.Patient stated they had difficulty breathing, nausea, headaches, and an upset stomach.Patient has no presence of rash, sores, swelling, or fever.Patient does not have any known allergies to plastic or disinfectants.Patient has not seen an allergist or primary care physician at this time, so no diagnosis has been made.The product was rinsed with water before seating and appeared to be clean before use.Customer attempted to trim the posterior of the devices to alleviate reaction but it did not resolve the issue.
Additional Manufacturer Narrative
Clearcorrect findings: patient began treatment approximately two weeks ago ((b)(6) 2023) and experienced a reaction at step 1.Patient stated they had difficulty breathing, nausea, headaches, and an upset stomach.Patient has no presence of rash, sores, swelling, or fever; no photos of patient or devices were received.Patient does not have any known allergies to plastic or disinfectants and has not seen an allergist or primary care physician at this time.The product was rinsed with water before seating and appeared to be clean before use.Customer attempted to trim the posterior region of the devices to alleviate reaction, but it did not resolve the issue.Customer advised patient to cease treatment, and stated the patient is feeling better.A review of the version 1-1 treatment setup and case ledger shows all protocols were followed.Clinical evaluation: although the provided information is brief, it is possible that the patient is having an allergic reaction.It is advised that patient discontinue aligner wear, if not already done so, and seek the consultation/care of an appropriate health care professional.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer (Section G): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• Manufacturer Contact: david jue ; 21 cypress blvd; round rock, TX 78665
• MDR Report Key: 17297846
• Report Number: 3007130440-2023-00002
• Device Sequence Number: 7061260
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52432917991795/16D20230526
• 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): 07/10/2023

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: 11/23/2024
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 17991795
• 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: 06/27/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female