MAUDE Adverse Event Report: KAVO DENTAL / KALTENBACH & VOIGT LUX M05L; HANDPIECE, AIR-POWERED, DENTAL

Model Number LUX M05L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/14/2020

Event Type  Injury  

Event Description

Small burn occurred through dry angle material after dental restoration using new handpiece.Fda safety report id# (b)(4).

• Brand Name: LUX M05L
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): KAVO DENTAL / KALTENBACH & VOIGT
• MDR Report Key: 9653754
• MDR Text Key: 177590763
• Report Number: MW5092664
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUX M05L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR