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

Model Number 200XDR

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

Patient Problem Burn, Thermal (2530)

Event Date 02/13/2014

Event Type  Injury  

Event Description

During a standard dental treatment the handpiece heated up and caused a burn on the lower lip to approximately the size of the handpiece's head.Patient was prescribed tylenol 3 with codeine and kenolog orabase ointment.Reference mfr report 3003637274-2014-00008.

• Brand Name: COMFORTDRIVE 200XDR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• MDR Report Key: 3720134
• MDR Text Key: 17840370
• Report Number: 1017522-2014-00003
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/17/2014

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 200XDR
• Device Catalogue Number: 1.007.3570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2014
• Distributor Facility Aware Date: 02/17/2014
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 02/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR