Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the impression kit 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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The customer reported an allergic reaction after using the impression kit.Medical intervention was not required, however, the customer required epinephrine.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).
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