Based on the information provided by the patient and internal investigation conducted by access dental lab, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions similar to an allergic reaction.
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Symptoms of allergic reaction in the form of swelling of the face, difficulty breathing, choking, pain and teeth sensitivity were developed by the patient.The customer required medical intervention and was prescribed with medications to help the symptoms subside.As a result, the patient discontinued the use of aligners.
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