No conclusive evidence has been provided that supports or opposes that fact that the aligners caused or contributed to the patients symptoms.This event is being filed as a mdr as the patient reported an allergic reaction episode while an smile direct club aligner system was being used.Although the initial submission was completed within the 30 calendar day reporting timeline, this mdr is being reported outside of the 30 calendar day reporting timeline due to an initial incomplete submission resulting in a lack of e-submission ack3 confirmation.
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