This incident is reportable according to 21 cfr 803.The fda defines this as a serious injury(21 cfr sec.803.3) as the office staff reported the patient having an allergic type reaction of mild respiratory difficulty approximately 1 hour after exposure to 2 products, one of which was a kulzer product, that required administration of benadryl by doctor.Symptoms resolved 2 hours after treatment.Allergy testing was stated to have been completed, but results have not been provided to the dental office at this time.Ifu states, "this product or one of its components may in particular cases cause hypersensitive reactions.The use of this product is contraindicated in case of known or suspected allergies against components of this product." the incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
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