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.This report is for the second patient.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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In this event it was reported that four patients experienced adverse reactions after use of integrity c&b material.In all of the cases, the oral tissue was red, inflamed and ulcerated.The patients were treated with cholorhexodine for the inflammation.One of the patients was reported to have an allergy to sulfa.
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