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

Reference importer report (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).Kavo dental (b)(4) (the manufacturer) is submitting the report on behalf of (b)(4) (the importer).

• 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: 3720119
• MDR Text Key: 4273076
• Report Number: 3003637274-2014-00008
• 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: 08/01/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1