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 12/05/2023

Event Type  Injury  

Event Description

Patient reported the following on 12/5/2023: patient (pt) expressed her frustration about her treatment which she feels had a long term effect with her mouth.After her initial report in december 2021 she stopped wearing her aligner step 8, she back then received a partial refund.And is reporting again because the effect from 2021 came back, she mentioned she's been seeing a couple of physicians about her case and is willing to submit what she has for documentation.Also,as per the patient.I have serious mouth issues due to the candid aligners.After the first infection allergic reaction, as time went on, it has caused a serious long term in which the inner mouth skin is prone to flare ups and infections after any minor injury.I'm on antibiotics twice a week such as clindamycin for 5 months since its all that works not steroids.I am not just sensitive to cold foods but spicy, sugar, sauces and acidic foods.Any injury with food or anything it automatically flares up and gets infected it is not normal.The candid aligners have set it off to major long term complications where it changed the inside of my skin prone to swelling, discomfort, pain, weak mouth and disalignment including aligner printed marks in my lips.Any injury that occurs my mouth or lips do not plump back without antibiotics.My health is in major risk as this puts me on antibiotics, benadryl and hydroxyzine every week.I have seen many specialist, they have seen my symptoms and reactions and they aren't able to find the solution.I have taken mri, ct scan, ultrasound and blood allergy tests and everything is normal however my facial and mouth swelling isn't.The plastic aligners were cheap materials and destructive disrupting my health, and daily living and i have not been able to work do to this".

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 which the patient stated resulted in medical treatment.

• 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 road; suite 307; columbus OH 43212
• Manufacturer Contact: jim churchill ; 1200 chambers road; suite 307; columbus, OH 43212 ; 8312471415
• MDR Report Key: 18451526
• MDR Text Key: 332259339
• Report Number: 3017264291-2024-00001
• Device Sequence Number: 1
• Product Code: NXC
• 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: 01/04/2024

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 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 35 YR
• Patient Sex: Female