Follow-up with the doctor determined that an error in their technique may have caused the chemical burns.During application of the prime & bond nt on a brush (instead of the applicator tip), a possible contamination of the gloves was described by the doctor.Furthermore, it was observed that the burns always occurred on the side of the treating dentist that typically would stabilize instruments by touching the site of burn with their gloved fingers.The dfu clearly warns users to avoid skin contact and gives instructions for what to do if skin contact is made.Since a serious injury resulted, this event is reportable per 21 cfr part 803.This report if for the fourth patient.The device was evaluated and found to be within specification.
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