MAUDE Adverse Event Report: KAVO DENTAL GMBH GENTLEPOWER LUX CONTRA ANGLE 25LPR; DENTAL HANDPIECE

Model Number 25LPR

Device Problems Overheating of Device (1437); Dent in Material (2526)

Patient Problem Burn, Thermal (2530)

Event Date 09/11/2014

Event Type  Injury  

Event Description

During a standard dental treatment on tooth# 13, 14, and 18 the head of the handpiece heated up and caused a burn on the lower lip.Patient did not receive any medication from dental office, but went to her physician on (b)(6) 2014.He prescribed an antibiotic amoxicillin 875mg and an ointment.

Manufacturer Narrative

The analysis did show that the handpiece had dents in the head and on the back cap.They cause the back cap sticking in which makes the back cap getting hot from rubbing on the drive.During test run it heated up right away.Grinding marks on the inside of back cap confirm the root cause.The dents show that the handpiece received a strong hit, e.G.By dropping during reprocessing.(b)(4).

• Brand Name: GENTLEPOWER LUX CONTRA ANGLE 25LPR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• Manufacturer Contact: klaus reisenauer ; bahnhofstrasse 20; warthausen ; GM ; 351561356
• MDR Report Key: 4172070
• MDR Text Key: 5159243
• Report Number: 3003637274-2014-00035
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25LPR
• Device Catalogue Number: 1.007.3580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Distributor Facility Aware Date: 09/15/2014
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 09/15/2014
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR