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

Lot Number 1383589

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 09/01/2023

Event Type  Injury  

Manufacturer Narrative

Clearcorrect findings: based on the case ledger the device was manufactured in june 13, 2023.No issues were identified based on the treatment setup and manufacturing log.Customer did not respond to three requests for additional information.Unable to determine any contributing factors.Clinical evaluation: the report of a possible allergic reaction is unsupported by any clinical or other patient data.Repeat requests to gain additional information were not responded.Until further information and details come forth, there is insufficient substance to continue further actions.Updated on november 17, 2023: based on the new information, there still appear to be errors of nomenclature and perhaps understanding.The complaint refers to the brackets.There are none.I assume that the reference is to engagers.Next, the complaint suggests the sores line up with the brackets and they do not.Aside from these inaccuracies, this seems to be a diagnostic error.The patient photographs demonstrate lesions that are pathognomonic of an episode of herpes simplex outbreak on the lower lip.This location, onset, and time frame of resolution are characteristic of an outbreak.The medical documentation states "lip licker dermatitis" which is what patients tend to do as the lesions become dry and painful so they constantly lick their lips.Not knowing the condition and the typical 2-3 weeks it takes to resolve, the clinician continued aligner wear which likely exasperated the situation.I will reserve judgment regarding the clinician's clinical ability, but the photographs show engagers that are tremendously overfilled with excessive flash.

Event Description

Clearcorrect territory manager contacted clearcorrect support to report a possible allergic reaction.No additional details were provided and no responses received to three follow up requests.Patient followed up on (b)(6) 2023 with the following information: aligners and lip journal day 1: friday (b)(6) 2023 sores begin developing more and soreness worsens.As one can see, the sores line up with the brackets decided to remove aligners in hopes the sores will begin healing day 3: sunday september 3, 2023 starting to feel better.No aligners day 4: monday (b)(6) 2023 looking and feeling better.No aligners day 5: (b)(6) 2023 went to see (b)(6) about the sores.Let him know i removed the liner 4 days ago because of severe soreness, swelling and pain day 8: friday (b)(6) 2023 1 week later, trying liner again day 9: saturday (b)(6) 2023 sores return immediately after putting the liner back in day 10: sunday (b)(6) 2023 ouch! day 12: tuesday (b)(6) 2023 go see(b)(6).Removed brackets in hopes the healing would begin day 14: thursday (b)(6) 2023 another week with liner and sores extremely sore.No brackets day 24: sunday (b)(6) 2023 heling begins again.No aligners.No brackets day 25: monday (b)(6)2023 time to see dermatologist to get medication to help the healing process dermatologist: see attached photos began treatment (b)(6) 2023 mix mupirocin and hydrocortisone twice a day for 2 weeks apply to lip (b)(6) 2023 end of treatment.Getting better discontinued the mix and put aligners in and try again.If sores come back, this in an indication of an allergic reaction to the aligners.(b)(6) 2023 started elta twice a day (b)(6)2023 2 days later with aligners in and sores immediately returned.I take the aligners out.By monday (b)(6) 2023 almost all healed.Feeling so much better.

• Brand Name: CLEARCORRECT SYSTEM
• Type of Device: 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: 18165414
• MDR Text Key: 328480582
• Report Number: 3007130440-2023-00009
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$52434818557296/16D20230614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1383589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Prefer Not To Disclose