Specific patient information with regard to gender, age, and weight was not provided.Although the office identified two (2) different lots associated with the gum irritation, the office could not verify which lot had been used on the patient.The lots involved in the alleged incident include lot numbers 5169229 and 4785393.The patient returned to the office and the excess cement was removed.The doctor also prescribed peridex for treatment of the symptoms.The symptoms had fully subsided after the temporaries were removed and the permanent crowns were placed.To date, the patient has fully recovered and is doing fine.The products involved in the alleged incidents were not returned; therefore, a retained sample from both lots was evaluated, yielding results within specifications.A dhr review indicated that there were no deviations from the manufacturing process for either lot.In addition, no similar complaints were received with regard to these lots.The tempspan transparent directions for use include a contraindication which states: "uncured methacrylate resin may cause contact dermatitis and damage the pulp.Avoid contact with skin, eyes, and soft tissue".
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