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

Model Number	Aligner (Multi-layer)
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	03/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the customer for case (b)(4) called in and stated the patient was having an allergic reaction from wearing the step 1 aligners after a full week of wear.The patient presented with a rash, sores in the mouth, and swelling.There was no fever or difficulty breathing.The patient, at the time, did not know of an allergy to plastic but has since seen a dermatologist and was diagnosed with a plastic allergy.The aligner was cleaned with water only prior to wear.
Additional Manufacturer Narrative
Clear correct findings: a review of the information provided shows the customer was unaware of existing allergy to plastic prior to starting treatment.The patient has stopped wearing the aligners and the issue was alleviated.Clinical evaluation: the accompanying information from the physician shows positive responses to methacrylate, cyanoacrylate, and other potential allergens.While methacrylate is found in many dental appliances, aligners are not formed from this type of plastic.Accordingly it is not possible to draw a direct cause and effect relationship with aligner wear and the patients symptoms.Nevertheless, the patient has discontinued aligner use and as such no additional risk exists to the patient.

• 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: raquel brown ; 21 cypress blvd; round rock, TX 78665 ; 8883313323
• MDR Report Key: 14193017
• Report Number: 3007130440-2022-00001
• Device Sequence Number: 17244910
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$5231166864425/16D20211026
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: 5113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 04/25/2023
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 2777797
• 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: 03/31/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2021
• 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: 61 YR
• Patient Sex: Female