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

Lot Number	1441129
Medical Device Problem Codes	Insufficient Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient has been having issues with her aligners.She thought at first they needed trimmed, and complained of her gums hurting.But came to the conclusion that she is allergic to a material that the aligners are made out of.Her gums swelled and burned every time she tried to wear them.She went to the emergency room and they advised her to not wear her aligners and to contact our office for further action on what to do.
Additional Manufacturer Narrative
Clearcorrect findings: patient was on step 1 when the symptoms started.Patient had difficulty breathing and a burning sensation.Patient has not been formally diagnosed with any allergies, but stated they had similar symptoms from other products such as acrylic nails and certain hair dyes.The device was rinsed before use with water and appeared to be clean, the reaction was not noticed until the patient was at home.Patient removed the devices after 3-4 hours of use with burning and itchy gingiva symptoms.The symptoms started to relieve after the aligners were removed.Photos were not taken of the reaction.A review of the treatment plan shows no issues that would contribute to patient discomfort.Case ledger indicates the devices were shipped on august 16, 2023.Clinical evaluation: the patient reported swollen gums, burning sensation as well as difficulty breathing when step 1 of the aligner series was worn.The symptoms were relieved after the aligners were discontinued and not worn.Unfortunately no clinical details regarding the description of the gums, locations and photographs were provided.A review of the treatment plan did not reveal any issues that could contribute to the patient's symptoms.Although the data are somewhat limited, there is sufficient information to suggest that allergic phenomenon may be responsible for the patient's symptoms.It is noted that the patient exhibited similar symptoms to hair dye and acrylic nails.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHDONTIC 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: 18144726
• Report Number: 3007130440-2023-00008
• Device Sequence Number: 11289900
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52504620135538/16D20230816
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/15/2023

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 Expiration Date: 02/15/2025
• Device Lot Number: 1441129
• 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: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Sex: Female