MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH ULTIMATE BA250LT; HANDPIECE

Model Number ULTIMATE BA250LT

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Date 10/03/2023

Event Type  Injury  

Event Description

Bur change button got extremely hot and burned patient's tongue and cheek.

• Brand Name: ULTIMATE BA250LT
• Type of Device: HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• MDR Report Key: 18088954
• MDR Text Key: 327587320
• Report Number: 3007007357-2023-00012
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ULTIMATE BA250LT
• Device Catalogue Number: BA250LT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2023
• Distributor Facility Aware Date: 10/30/2023
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female