In this event it is reported allergic reaction to students reportedly occurred using jelt chroma f/s 454gm pch/jeltrate chroma dustless alginate - for use by the students during this academic year.The students experienced adverse reactions including ulcers, blisters, and mucositis after using the product.Further information requested.
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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 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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