MAUDE Adverse Event Report: CLEARCORRECT CLEARCORRECT; 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	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: a review of the product floor was performed where it was confirmed that processes were being performed as procedurally required.A review was performed where it was confirmed there were no similar complaints for other parts shipped out the same day, thus the event was isolated to this case.Clinical evaluation: the reported signs and symptoms are suggestive of an immune response.The timing is proximal to aligner wear and the possibility of an allergic reaction cannot be ruled out.Accompanying photos show an engager on the left lateral incisor.Materials involved with engager placement may also be considered as possible allergans.The panoramic radiograph shows generalized bone loss with severe angular bone loss on the mesial of the maxillary left canine which is the location of the erythematous gingiva.Periodontal disease may be an etiology of the gingival appearance.Lastly, idiopathic allergic reactions are not uncommon and this report may be coincident with such an incident.The limited information and lack of medical confirmation leave the cause of the signs and symptoms indeterminate.
Event or Problem Description
The customer reports the patient started experiencing an itchy and painful throat after the first night of wearing the aligners.The following morning a rash was present on the left side of the patient's face and some slight swelling of the gums.There was no fever, sores, or difficulty breathing.Patient has no known allergies to plastic or disinfectants.The product was washed with water prior to insertion.The customer had the patient immediately stop wearing the aligners and the gums are now better.No mention of the throat pain or rash alleviation.

• Brand Name: CLEARCORRECT
• 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 ; 8883313233
• MDR Report Key: 15635762
• Report Number: 3007130440-2022-00009
• Device Sequence Number: 17936770
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52405712406592/16D20220830
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Company Representative
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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
• Device Expiration Date: 02/28/2022
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 3191084
• 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: 09/22/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 45 YR
• Patient Sex: Female