(b)(4).This is a serious injury (as defined in 21 cfr section 803.3) as the patient reported having an adverse reaction.Because the malfunction allegation could not be confirmed, the cause of the adverse reaction could not be determined.This incident is being reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.Narrative for method/results/conclusion code directions for use indicate rubber dam use is required.The office used only cotton rolls for isolation, which is inadequate.Device not returned.
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