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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL / KALTENBACH & VOIGT LUX M05L HANDPIECE, AIR-POWERED, DENTAL

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KAVO DENTAL / KALTENBACH & VOIGT LUX M05L HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Model Number LUX M05L
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 01/14/2020
Event Type  Injury  
Event Description
Small burn occurred through dry angle material after dental restoration using new handpiece. Fda safety report id# (b)(4).
 
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Brand NameLUX M05L
Type of DeviceHANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
KAVO DENTAL / KALTENBACH & VOIGT
MDR Report Key9653754
MDR Text Key177590763
Report NumberMW5092664
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberLUX M05L
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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