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

Lot Number	1560405
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing ledger indicates the step 1 upper and lower devices were produced on january 6, 2024 on the same production line.There have been no updates/changes to the manufacturing process or materials leading to or during the time of production.The customer advised the patient to cease treatment.Patient stated they had a fever and swelling, but no difficulty breathing.Patient was unaware of any previous allergy to plastic or disinfectants.However, the customer noted, "the shape of the inflamed spot on her [arm] mimics the shape of the aligners that she put against her skin to test." the patient cleaned the devices with water, and the customer stated the devices appear to be clean.The patient did seek medical attention from their primary care physician and had to undergo "aggressive steroid therapy." the patient was prescribed steroids, and the symptoms have dissipated.Clinical evaluation: the complaint is one of a potential allergic reaction to the aligner.It is noted that it was cleaned with water prior to wear.A description of the shape of the inflamed reaction on her arm was in the same shape as the aligner.The photographs show an arm with at least 3 generally ovoid shaped areas of redness but not clearly defined as an aligner.The arm also has number of circular red lesions closer to the elbow.A photograph of a hand shows inflammation on the hand near the index finger.It is also noted that the patient responded to "agressive steroid therapy".With the information provided it is not possible to rule out an allergic response.However, with the collective information provided, it is suggestive of a more generalized condition that is coincident with aligner wear.Allergic reactions are a known undesired side-effect of the clearcorrect system and documented in the instructions for use.The occurrences of potential allergic reactions are closely monitored via post-market surveillance.The trending data indicates no negative impacts to risk/benefit, and the occurrence rate is within the expected range.
Event or Problem Description
Customer contacted clearcorrect customer care and stated that the patient experienced a possible allergic reaction.The customer stated the reaction started immediately after starting treatment.The clinician advised the patient to cease treatment.The patient was prescribed steroid therapy to treat the symptoms; symptoms have completely dissipated.

• 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: 19182209
• Report Number: 3007130440-2024-00003
• Device Sequence Number: 7231992
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52518923383934/16D20240108
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/24/2024

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: 07/08/2025
• Device Lot Number: 1560405
• 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: Not provided
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Prefer Not To Disclose