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

Lot Number	3183170
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider's office called in to say the patient was having an allergic reaction to the aligners.She said the patient was having a hard time breathing and swelling in the mouth.The patient is not currently wearing the aligners and should be sending back the aligners with the shipping label provided.Provider states the patient has no presence of a rash or fever, however, there are sores present along with a red throat, and anaphylaxis.Prior to treatment there was no known allergy to plastic or any other allergies.After the issue was reported the patient then stated she is allergic to a lot of things (this was not expanded on).The aligner was not rinsed or cleaned with anything, it was stated "the aligner was pulled straight from the package".The patient is no longer wearing the aligners and plans to see her primary care physician after she gets back into from vacation.Patient has not reported back to the provider.
Additional Manufacturer Narrative
Clearcorrect findings: a review of the product floor was performed where it was confirmed that processes were being performed as procedurally required.A review was performed where it was confirmed there were no similar complaints for other parts shipped out the same day, thus the event was isolated to this case.Clinical evaluation: follow up information from the physician and allergist would be helpful to determine any relationship with the aligner wear and the reported symptoms.At this time, with the limited information provided, it is possible that the patient had an allergic reaction to the aligner, materials used to manufacture the aligner or engagers and related materials.There is no mention of use of the latter in this report.At this time the patient has stopped wearing the aligners and there is no additional medical risk to the patient.

• Brand Name: CLEARCORRECT
• 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: raquel brown ; 21 cypress blvd; round rock, TX 78665 ; 8883313323
• MDR Report Key: 15632203
• Report Number: 3007130440-2022-00006
• Device Sequence Number: 15455701
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/4452405412294869416D20220825/S23255514F
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Company Representative
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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 Expiration Date: 02/25/2024
• Device Lot Number: 3183170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2022
• 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 Sex: Prefer Not To Disclose