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 not returned for evaluation.However, the serial/order/lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
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In this event it is reported that a patient experienced allergic reaction during the use of aligner use.Reportedly, the reaction that the patient included swollen/red gingiva and a burning sensation.The patient initially received antibiotics from a physician as it was suspected that she had an infection.The infection was later ruled out by the doctor and reportedly, confirmed allergic reaction to the aligners.Symptoms resolved after 3-5 days of discontinuing aligner wear.No known additional medical intervention was required.
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