Based on the information provided by the patient, 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 related to infection.
|
The customer reported infection between teeth 22 & 27 while wearing the aligners.Medical intervention was required, and teeth extraction could be performed.The treatment was discontinued.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).
|