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

Model Number	Aligner (Single-Layer)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation findings: the customer sent in screenshots of a text conversation with the patient.Patient states after opening step 5 and wearing it her lips, tongue, and inside of her mouth swelled up.Patient went to urgent care where she was given an epipen and other medications for the reaction.A review of batch 253799 was performed where it was confirmed there were no similar complaints, thus the event was isolated to this case.Clinical evaluation: an allergic reaction can be a moderate medical risk to the patient.Regulatory evaluation: this event occurred at the start of treatment step 5; the account did not indicate if the patient exhibited any signs of allergic reaction during steps 1 to 4.While the complaint implies an allergic reaction, it is not certain that it is associated with the device.Because the event did not occur until step 5, it is not an acute reaction that would require medical intervention to avoid permanent harm or death.The patient did seek medical treatment and was prescribed an epipen.It is not clear whether the epipen or some other intervention was at the time the patient sought treatment.Because it appears that medical intervention was performed in this event, this event meets the criteria for adverse event reporting.
Event or Problem Description
The patient's lips, tongue, and mouth swelled up.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT LLC; 21 cypress blvd; round rock TX 78665
• MDR Report Key: 10610262
• Report Number: 3007130440-2020-00002
• Device Sequence Number: 1281947
• Product Code: NXC
• UDI-Device Identifier: D865REF00011
• UDI-Public: +D865REF00011/$$523168253799/16D20200617
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: No Information
• Device Expiration Date: 12/14/2021
• Device Model Number: Aligner (Single-Layer)
• Device Catalogue Number: REF-01
• Device Lot Number: 253799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR