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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC MARUS LUXSTAR; DENTAL LIGHT
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KAVO DENTAL TECHNOLOGIES, LLC MARUS LUXSTAR; DENTAL LIGHT Back to Search Results
Model Number WL1000
Device Problem Device Handling Problem (3265)
Patient Problem Burning Sensation (2146)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
The onsite dental service technician visually inspected the marus dental light at the doctors office.It was identified that the tether was not attached to the lens heat shield cover.The tether will prevent the lens heat shield cover from falling off the light if it is not properly reinstalled after routine maintenance.The lenses heat shield cover has to be removed during routine maintenance when replacing the halogen light bulb or cleaning the lens covers.On 10/7/2021, it was confirmed with the customer that the recommended replacement parts including the tether had been installed onto the light.This concludes the investigation.
 
Event Description
A dental professional was treating a patient when the lens heat shield cover fell off a marus dental light hitting the patient causing a small burn.There were no serious injuries reported.
 
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Brand Name
MARUS LUXSTAR
Type of Device
DENTAL LIGHT
Manufacturer (Section D)
KAVO DENTAL TECHNOLOGIES, LLC
11727 fruehauf drive
charlotte NC 28273
MDR Report Key12615411
MDR Text Key281429807
Report Number1017522-2021-00006
Device Sequence Number1
Product Code EAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWL1000
Device Catalogue Number0.842.9000
Was Device Available for Evaluation? No
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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