MAUDE Adverse Event Report: DENTAL DRILL; DRILL, DENTAL, INTRAORAL

Device Problem Overheating of Device (1437)

Patient Problems Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694); Blister (4537)

Event Date 05/19/2021

Event Type  Injury  

Event Description

While having a crown build up performed by a dentist, i sustained, at minimum, second degree burns on my lip due to a dental drill over heating.Blistering and change of skin color was noted by the patient (myself) within minutes after the conclusion of the appointment.Dental staff did not mention oromucosal damage to the patient during or at the end of the procedure.Burning was not felt during the procedure due to local anesthesia.Given that the injury occurred in the evening, and the dental office was closed at the time the injury was noticed by the patient, the dental office was informed the following morning.The patient required follow up with a physician the following morning; the injury is being monitored for infection.Additional medical follow up is likely to be needed.Fda safety report id# (b)(4).

• Brand Name: DENTAL DRILL
• Type of Device: DRILL, DENTAL, INTRAORAL
• MDR Report Key: 11875006
• MDR Text Key: 252708894
• Report Number: MW5101527
• Device Sequence Number: 1
• Product Code: DZA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR