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 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 patient using non-template aligner arch for treatment experienced allergic reaction.Their symptoms included, rash, swelling of the throat and difficulty swallowing.It is reported that the patient has a number of known allergies including plastic, that they were also using a name brand appliance cleaner that may have also caused or contributed to the reaction.Their symptoms resolved on their own immediately after discontinuing aliger treatment.
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