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

Model Number Aligner (Multi-layer)

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/27/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 318862775
• Report Number: 3007130440-2023-00002
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52432917991795/16D20230526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female