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

Model Number	Aligner (Multi-layer)
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 (b)(6) with the provider's office called about case (b)(4) and says that the patient was having an allergic reaction to the aligners.The patient did not progress past step 1 aligner when the reaction was noticed.The provider services specialist was informed that the aligners made the patient's hands red, her throat became itchy and irritable, and her lips started swelling.The provider services specialist was informed that the aligner caused the patient to have an asthma attack.(b)(6) with the provider's office stated the patient had to go to the pulmonary doctor regarding the event.The provider services specialist was informed that the patient has many allergies, but (b)(6) with the provider's office was not sure if plastic was one of them.Per (b)(6), the provider and the customer only rinse the aligners with water.
Additional Manufacturer Narrative
Clearcorrect findings: based on the description of the patient's reaction, the customer is stating that the patient has had an allergic reaction but is not sure if the patient has been assessed allergies to plastic.Review of the production process shows no changes that could induce new substances that may contribute to allergic reactions.Customer was informed to have the patient discontinue treatment.The case has been cancelled as on (b)(6) 2021.As of november 24, 2021, no additional information has been provided from the customer.A request to return the product has been sent to the customer.Clinical evaluation: from the information provided, it appears that the patient is hyper-allergenic but does not indicate if the patient has had allergic reactions to plastic in the past.It is also remarkable that the patient's hands, throat and lips were affected.It is unclear whether the symptoms were due to the aligners or other etiology that was coincident with aligner wear.The patient was referred to a physician for evaluation and advised to discontinue aligner wear.As such, there is no further medical risk to the patient.

• Brand Name: CLEARCORRECT SYSTEM
• 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 ; 8883313323
• MDR Report Key: 13019112
• Report Number: 3007130440-2021-00006
• Device Sequence Number: 4803709
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$5230946486844/16D20211004
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: 04/03/2023
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 2748646
• 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: 11/17/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 59 YR
• Patient Sex: Female