MAUDE Adverse Event Report: KAVO DENTAL GMBH COMFORTDRIVE 200XDR; DENTAL HANDPIECE

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

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

The analysis of the handpiece did show that the head had a dent.This indicates that it received a strong hit, e.G.Due to dropping.This caused the push button to stick in, causing inner friction and hence increase of temperature.The user instruction requests that prior to each treatment a functional and visual inspection has to be performed to ensure that the product is running within specification.(b)(4).

• Brand Name: COMFORTDRIVE 200XDR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach 88400 ; GM 88400 ; 351561356
• MDR Report Key: 3720133
• MDR Text Key: 18310498
• Report Number: 3003637274-2014-00009
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K080677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1