MAUDE Adverse Event Report: KAVO DENTAL GMBH / KALTENBACH AND VOIGT GMBH HANDPIECE, AIR POWERED DENTAL

Model Number LUX M05L

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 01/20/2020

Event Type  malfunction  

Event Description

Using dental handpiece and felt excess heat on handpiece during use resulting in small burn to pt's lower lip.Fda safety report id# (b)(4).

• Brand Name: HANDPIECE, AIR POWERED DENTAL
• Type of Device: HANDPIECE, AIR POWERED DENTAL
• Manufacturer (Section D): KAVO DENTAL GMBH / KALTENBACH AND VOIGT GMBH
• MDR Report Key: 9665422
• MDR Text Key: 177883600
• Report Number: MW5092722
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this a Product Problem 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: 3 YR