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

Lot Number	1459259
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: the patient states she is following the correct wear schedule and wearing them all day, and she is using painkillers.The clinician advised her to stop wearing the devices for 2 days and booked an urgent appointment for her to come in.The patient was seen on saturday, (b)(6) 2023.And a clinical examination was performed.The clinician stated, "no ulcers were found, only linea alba on right cheek and some redness around the area of the rugae (behind the upper central incisors).The device was smoothed at the area of irritation (rugae).The patient says it is still slightly sore, and the pain is decreasing after she used antihistamines.The patient said she went to the pharmacist and was advised to use the antihistamine "bonjela" the clinician suggested that it may be some kind of allergy to the device.The patient then remembered that she has an allergy to latex and cardboard.No photos were provided during the initial contact.Clinical evaluation: the tissue irritation and ulceration as well as tongue soreness are suggestive of mechanical trauma related to the fitment of the aligner.The aligner was smoothed at the area of irritation (palatal rugae) which led to reduction in pain and further supports this etiology.No clinical photographs were provided and the only known allergies are to latex and cardboard.No information was provided regarding whether the patient resumed aligner wear or not.Some symptoms may be indicative of an allergic reaction.
Event or Problem Description
On (b)(6) 2023 the clinician contacted clearcorrect support and stated: the patient began treatment in the beginning of (b)(6) 2023, and reported to the practice that she woke up due to pain in her upper canines at 3am; the pain severity was 5/10, ulcers on her cheeks and side of tongue, soreness on the roof of her mouth and behind her anterior teeth, inability to speak normally at work, and general discomfort.

• 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: david jue ; 21 cypress blvd; round rock, TX 78665
• MDR Report Key: 18006737
• Report Number: 3007130440-2023-00005
• Device Sequence Number: 20757297
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52508020880295/16D20230922
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Notification
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: 03/21/2025
• Device Lot Number: 1459259
• 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: 10/17/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Prefer Not To Disclose