The current instructions for use (ifu) contains the following: "warning - in rare instances, some patient may be allergic to the plastic aligner material, discontinue use and consult a health care professional immediately." the potential root cause is unknown.No conclusive evidence has been provided that supports or opposes the fact that the invisalign aligners caused or contributed to the reported symptom.This event is being filed as an mdr as the patient reported an anaphylactic reaction and an invisalign product was being used.
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