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

Model Number 251PR

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

During a dental treatment, the handpiece heated up and caused a burn mark on pt's tongue.No medication was necessary.Further info are not available, yet.On (b)(6) 2014 21:01:26 (b)(6) informed me about pt being burned at dr.(b)(6)'s office.She said this handpiece came in only once to (b)(6).Completed cleaning/lube/test of handpiece and shipped it back to doctor on (b)(6) 2014.I called office and spoke with (b)(6).She did not know pt's name to pull chart.(b)(6) said while working on left side of mouth, the pt was burned on tongue to the size of about a dime.Pt is female in her (b)(6)'s.No ointment or medication given to pt for burn.Office does not have safe drive equipment.Office will mail the handpiece to (b)(6) to be forwarded to kavo us.I explained to (b)(6) that i will call her back after tech was evaluated the handpiece.

Manufacturer Narrative

The handpiece has not been sent in for an analysis, yet.But it is confirmed that it will be sent from the (b)(4) dealer to kavo us for investigation.A f/u report will be sent as soon as further details are available.

• 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 ; mismarckring 39; biberch 88400 ; GM 88400 ; 351561356
• MDR Report Key: 4379912
• MDR Text Key: 18730212
• Report Number: 3003637274-2014-00039
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 251PR
• Device Catalogue Number: 1.007.3580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR