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	09/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation findings: a review of the photos sent in by the customer shows the patient is having a reaction to the aligners.The patient did go see a physician who diagnosed her as having an allergic reaction to the aligner material.No errors were found with the orthobased files and all protocols were followed during the cut and stage process.The patient does not have any previous known allergies to or sensitivities.The customer did not rinse the aligners prior to seating them on the patient and the aligners were not altered in any way.A review of batch 263349 was performed and confirmed to not contain similar complaints, therefore event is isolated to this case.Clinical evaluation: the attached photos show an apparent allergic reaction to the aligners.The patient was accordingly told to discontinue wearing the aligners.Continuing to wear the aligners could be a moderate medical risk to the patient.Regulatory evaluation: apparent allergic reaction.Medical intervention was taken in this instance (steroid injection).The event does meet the criteria for adverse event reporting.
Event or Problem Description
Customer states: i just started this case on my patient, and she had an obvious allergic reaction to the aligners and required discontinuation of treatment.Reaction progressed from small localized ulcerations on her lips to larger more generalized lesions and swelling of the lips.Patient presented to her physician and was diagnosed with allergy to the aligner material and instructed to remove them immediately and was treated with steroids.

• 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: 10614003
• Report Number: 3007130440-2020-00003
• Device Sequence Number: 11445616
• Product Code: NXC
• UDI-Device Identifier: D865REF00011
• UDI-Public: +D865REF00011/$$523219263349/16D20200807
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 10/01/2020

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: 02/07/2021
• Device Model Number: Aligner (Single-Layer)
• Device Catalogue Number: REF-01
• Device Lot Number: 263349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 10/01/2020
• 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