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

Lot Number	1474762
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clearcorrect findings: no photos were received of the reaction.It is unknown if the patient has any pre-existing allergies to plastics.The material spec sheet was sent to the clinician and follow-up information has been requested.Clinical evaluation: the timeline of the reaction within minutes is suggestive of phenomenon such as chemical burn or allergy.It is not clear if the blisters developed immediately or some time later.Essential details were not provided in this report.It would be important to know if any rinses/agents were used to clean the aligners, relevant medical history including alleries, and photographic documentation.Accordingly with the sparse information provided it is not possible to be conclusive but an allergic reaction cannot be ruled out.
Event or Problem Description
On (b)(6) 2023 the sales rep contacted support and stated: please note we have been advised by the clinician that the patient may be suffering adverse reactions to the aligners.(b)(6) 2023 - dr gheorghe emailed the following advisory: as per our phone conversation regarding my clear correct patient, i saw him during a review and indeed he developed an allergy to cc aligners.Very unusual for myself as well as we discussed.He had the aligners with him and asked him to wear them and minutes later the gum and lips started to change colour, developing small kind of blisters on gingiva.

• 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: 17901639
• Report Number: 3007130440-2023-00004
• Device Sequence Number: 16985876
• Product Code: NXC
• UDI-Device Identifier: D865REF03001
• UDI-Public: +D865REF03001/$$52507220572310/16D20230914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/09/2023

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: 03/08/2025
• Device Lot Number: 1474762
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2023
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male