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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL GMBH GENTLEPOWER LUX CONTRA ANGLE 25LPA; DENTAL HANDPIECE
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KAVO DENTAL GMBH GENTLEPOWER LUX CONTRA ANGLE 25LPA; DENTAL HANDPIECE Back to Search Results
Model Number 25LPA
Device Problem Overheating of Device (1437)
Patient Problem Burn, Thermal (2530)
Event Date 12/06/2013
Event Type  Injury  
Event Description
During a standard dental treatment the head of the handpiece heated up and caused a burn on the upper and lower right lip.The size is approximately the size of the nickle.The pt was prescribed bacitracin ointment.Please refer to mfr report # 3003637274-2014-00001.
 
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Brand Name
GENTLEPOWER LUX CONTRA ANGLE 25LPA
Type of Device
DENTAL HANDPIECE
Manufacturer (Section D)
KAVO DENTAL GMBH
bahnhofstrasse 20
warthausen 8844 7
GM  88447
Manufacturer (Section G)
PELTON & CRANE
11727 fruehauf dr.
charlotte NC 28273
Manufacturer Contact
11727 fruehauf dr.
charlotte, NC 28273
MDR Report Key3610704
MDR Text Key19195345
Report Number1017522-2014-00001
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Dentist
Type of Report Initial
Report Date 12/13/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25LPA
Device Catalogue Number1.002.1526
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/13/2013
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2014
Distributor Facility Aware Date12/13/2013
Device Age7 YR
Event Location Other
Date Report to Manufacturer12/13/2013
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/13/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
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