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

Catalog Number 112-5813

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 02/13/2018

Event Type  Injury  

Event Description

Doctor was performing crown prep on the right side of the patient's mouth on tooth# 30 and the head of the handpiece heated up with full water spray enabled, to the point that it burned a perfect circle the size of the hp head on the inside of the patient's right cheek.The patient was given oralone and keflex for the burn.

• Brand Name: HENRY SCHEIN
• Type of Device: HANDPIECE
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim hessen, D-646 25; GM D-64625
• MDR Report Key: 7699035
• MDR Text Key: 114337965
• Report Number: 3002466018-2018-00050
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 112-5813
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2018
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR