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

Model Number	Retainer
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Charmaine from the customer's office called in stating the patient for case # (b)(4) wore all steps of treatment with no trouble, but claims she is experiencing an allergic reaction to the retainers.The patient is currently wearing upper and lower retainer and appears to have a presence of swelling of the mouth and lips with some hives.The patient does not have any difficulty breathing, no known allergy to plastic and disinfectants.The product was rinsed using polydent and appear to be clean.The patient has since taken allergy medication and seen their primary physician and waiting on results from their blood test.Photos have been included.The patient is particularly concerned because we are not going to remake the retainers out of the new material so the patient might not return them.It was advised to discontinue the use of the retainer until we have more information.
Additional Manufacturer Narrative
Clearcorrect findings: very little information was provided for this complaint and the results of the blood work are still pending.I reviewed the case and found no areas of concern.A review of the product floor was performed where it was confirmed that processes were being performed as procedurally required.A review of batch 341673 was performed where it was confirmed there were no similar complaints, thus the event was isolated to this case.Additionally, the customer did use polydent on the treatment aligners as well with no reaction to the product.In reviewing the materials used it was found the patient's treatment aligners were made using the new flex material (ref-03 multi-layer), which is composed of an inner layer material called polyurethane and an outer layer material called polyethylene terephthalate glycol.The outer layer is the layer of the aligner that makes contact with the patient's tissue.The retainers, where the patient experienced the reaction, is made using the polyurethane which was the layer of the treatment aligners that the patient was not exposed to during treatment.Clinical evaluation: it appears the complaint is focused on the patients swelling of lips, areas of the mouth and hives.There are no further details regarding onset, location of the hives and other details which may be informative.The report also indicates that the patient has been to a physician and results of laboratory tests are not yet available.At this time there is insufficient information regarding the symptoms to make any conclusive statements or assessments of relative risk.By way of background information, there are a number of possible causes for the reported symptoms which include food allergens and components in cosmetics and lipstick.Updated information regarding the material (isoplast) was provided.However additional information from the patient's physician and/or laboratory tests was not provided.Also no updates regarding resolution of the issue are available.Without details any relationship between cause and effect are inconclusive.

• Brand Name: CLEARCORRECT SYSTEM
• Common Device Name: CLEAR PLASTIC ORTHODONTIC ALIGNER
• Manufacturer (Section D): CLEARCORRECT; 21 cypress blvd; round rock TX 78665
• MDR Report Key: 12423335
• Report Number: 3007130440-2021-00004
• Device Sequence Number: 11658155
• Product Code: NXC
• UDI-Device Identifier: D865REF00041
• UDI-Public: +D865REF00041/$$523016341673/16D20210716
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2023
• Device Model Number: Retainer
• Device Catalogue Number: REF-04
• Device Lot Number: 341673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR