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

Model Number Aligner (Multi-layer)

Device Problem Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 09/07/2022

Event Type  Injury  

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: the information from dr.(b)(6) does not substantively add to an understanding of the issue.Qualified information from the physician/allergist is indicated.At this time, the patient has discontinued aligner wear and as such there is no additional risk to the patient.

Event Description

Dr.(b)(6) reported that her patient after wearing the 2nd tray begin to have difficulty breathing.The patient previously suffered from asthma per dr.(b)(6).She indicated that he started using an inhaler but also indicated that he had not had asthma in over 5 years until waring the aligners.She had the patient stop wearing the aligners and called to ask about stopping the case and asked about the material.There is no presence of a rash, sores, swelling, or fever.The patient has not gone to see their primary care physician and no indication of whether or not he will.

• Brand Name: CLEARCORRECT
• 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: raquel brown ; 21 cypress blvd; round rock, TX 78665 ; 8883313233
• MDR Report Key: 15633197
• MDR Text Key: 302012805
• Report Number: 3007130440-2022-00007
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: D865REF00031
• UDI-Public: +D865REF00031/$$5232599108727/16D20220316
• 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: Company Representative
• Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/19/2023
• Device Model Number: Aligner (Multi-layer)
• Device Catalogue Number: REF-03
• Device Lot Number: 2951647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male