MAUDE Adverse Event Report: KAVO DENTAL GMBH GENTLEPOWER LUX 25LPA; HANDPIECE, AIR-POWERED, DENTAL

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 10/08/2021

Event Type  malfunction  

Event Description

Dentist had started to drill on tooth of a patient and noticed that the electric handpiece she was utilizing was getting warm.She stopped drilling and inspected the handpiece and mouth.Noticed a 10mm x 6mm burn on right side of lower lip.Fda safety report id # (b)(4).

• Brand Name: GENTLEPOWER LUX 25LPA
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): KAVO DENTAL GMBH
• MDR Report Key: 12633217
• MDR Text Key: 276695443
• Report Number: MW5104599
• Device Sequence Number: 1
• Product Code: EFB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 6 YR
• Patient Weight: 26