MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MAXIMA ELITE BY HENRY SCHEIN; DENTAL HANDPIECE

Model Number 1:5

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/18/2019

Event Type  Injury  

Event Description

Female patient experienced discomfort while dentist was using the handpiece, and notified the dentist immediately.The male patient was numbed at the time and did not notice anything.However, the dentist saw white patch forming and stopped using the handpiece.A white patch formed on the female patient as well.Neither patient received medical attention.

• Brand Name: MAXIMA ELITE BY HENRY SCHEIN
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, D-646 25; GM D-64625
• MDR Report Key: 9497923
• MDR Text Key: 172274691
• Report Number: 3007007357-2019-00006
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1:5
• Device Catalogue Number: 112-5681
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Distributor Facility Aware Date: 12/05/2019
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other