While it is unknown if the device used in this case caused or contributed to the patient's symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
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