MAUDE Adverse Event Report: CLEARCORRECT 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	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending information: was the patient given any type of medication to alleviate the reaction? does the patient have a history of dental diseases that would prevent movement? what step was the patient wearing when this was first observed? were the trays rinsed before being seated? what has been used to clean the aligners? what are the signs and symptoms being expressed? has the patient seen their primary care physician or a specialist? if so, what were the results? has the device been modified in any way? how has the device been modified? are abrasions present? details of abrasions.A review of the production floor was performed where it was confirmed that processes were being performed as procedurally required.A review of batch 267436 was performed where it was confirmed there were no similar complaints, thus the event was isolated to this case.Attempts to collect additional information listed above produced no results as the provider has not responded to attempts.Clinical evaluation was inconclusive due to lack of information from customer.Regulatory evaluation: based upon the complaint details available, the circumstances regarding the patient reaction are not clear.There is no discussion regarding the severity of the reaction or the treatment step.The complaint does imply that the patient is seeking medical assessment for the potential allergy.Based solely on the fact that the patient is seeking further medical assessment, we shall treat this as a reportable event unless further information indicates that no further intervention was necessary.
Event or Problem Description
Customer reported that case #(b)(4) patient is having an allergic reaction from the phase 1 step 1 aligners.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• MDR Report Key: 10838957
• Report Number: 3007130440-2020-00005
• Device Sequence Number: 11784550
• Product Code: NXC
• UDI-Device Identifier: D865REF00011
• UDI-Public: +D865REF00011/$$522060267436/16D20200901/S12804344U+D865REF00011/$$522060267436/16D20200901
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K113618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: Aligner (Single-Layer)
• Device Catalogue Number: REF-01
• Device Lot Number: 267436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/13/2020
• 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: Other
• Patient Age: 32 YR