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

Model Number FA-0001

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/05/2024

Event Type  Injury  

Event Description

The patient reported the following: patient called to let me know she has asthma and allergy issues.Since beginning her treatment with candid, she has had difficulty breathing.At the direction of her allergy doctor, she stopped wearing her aligners for a few days.During the course of not wearing her aligners, she believes she was breathing better.

Manufacturer Narrative

Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological condition related to allergic reaction.

• Brand Name: CANDID ALIGNER SYSTEM
• Type of Device: ALIGNER SEQUENTIAL
• Manufacturer (Section D): CANDID CARE CO; 1200 chambers road; suite 307; columbus OH 43212
• Manufacturer (Section G): CANDID CARE CO; 1200 chambers rd; suite 307; columbus OH 43212
• Manufacturer Contact: jim churchill ; 1200 chambers rd; suite 307; columbus, OH 43212 ; 8312471415
• MDR Report Key: 19006126
• MDR Text Key: 338935510
• Report Number: 3017264-2024-00004
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00850004223567
• UDI-Public: 00850004223567
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FA-0001
• Device Catalogue Number: FGS-0002
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female