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U.S. Department of Health and Human Services

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

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KAVO DENTAL GMBH GENTLEPOWER LUX CONTRA ANGLE 25LPR; DENTAL HANDPIECE Back to Search Results
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.
 
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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 Key4379912
MDR Text Key18730212
Report Number3003637274-2014-00039
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K073478
Number of Events Reported1
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 Number251PR
Device Catalogue Number1.007.3580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2014
Initial Date FDA Received12/29/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age50 YR
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