MAUDE Adverse Event Report: CANDID CARE CO. CANDID ALIGNER SYSTEM; ALIGNER SEQUENTIAL

Model Number	FA-0001
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The provider/patient reported the following:: "i've been having bad sinus issues, sore throat.It's from the aligners.I started set 2 today but it's really been negatively impacting my work, sleep, sinuses, etc." here is one intra-oral photo he sent over complaining of his throat hurting.After talking with him and explaining a few times that it's normal to have tenderness and sometimes a little bit of pain with aligners, especially when beginning a new set.He still wants to call it quits.Here's what he's last said to me "i'm unfortunately unable to continue my aligners.I have been trying up through yesterday but they just aren't working for me right now.They cause headaches, and sinus pressure every time i put them in.It's still impacting my sleep and work.With current life situation / work, i can't do it.".
Additional Manufacturer Narrative
Based on the information provided by the provider/patient, there is no conclusive evidence that supports or opposes the tact that the aligners caused, contributed or would likely cause or contribute to the reported event.This eveneis being file as a mdt since the patient reported symptoms or physiological condition related to an allergic reaction.

• Brand Name: CANDID ALIGNER SYSTEM
• Common Device Name: ALIGNER SEQUENTIAL
• Manufacturer (Section D): CANDID CARE CO.; 1200 chambers road; suite 307; columbus OH 43212
• Manufacturer (Section G): CANDID CARE CO.; 1200 chambers road; suite 307; columbus OH 43212
• Manufacturer Contact: jim churchill ; 1200 chambers road; suite 307; columbus, OH 43212 ; 8442956915
• MDR Report Key: 23576031
• Report Number: 3017264291-2025-00017
• Device Sequence Number: 9259621
• Product Code: NXC
• UDI-Device Identifier: 00850004223567
• UDI-Public: 00850004223567
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190938
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2025

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 Model Number: FA-0001
• Device Catalogue Number: FGS-0002
• Device Lot Number: N/A
• 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: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2025
• 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: 33 YR
• Patient Sex: Male