On october 28, 2022 in a complaint investigation follow-up call the clinician (and endodontist) who performed the root canal procedure confirmed the patient had developed a rash throughout their body and that medical intervention in the form of an oral steroid was provided to help clear up the rash.The also clinician confirmed that the patient showed no signs of distress.Several instruments and chemicals where used in the treatment, neosealer flo being one.While these other chemicals may have caused the rash, neosealer flo could not be entirely dismissed as allergic responses to many dental materials are possible.While no impairment to the function or permanent damage of the body occurred, the manufacturer has chosen to take a proactive response to this case and report in compliance with 21 cfr part 803.There has never been a previous report of allergic responses regarding this product or any other products with similar chemistry from the manufacturer.
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