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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH HIGH-SPEED DENTAL HANDPIECE

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LARES RESEARCH LARES RESEARCH HIGH-SPEED DENTAL HANDPIECE Back to Search Results
Model Number 757 ULTRALITE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Device user stated they had the handpiece repaired at an unauthorized repair business. A device investigation established the turbine in the handpiece did have components that were not installed by the original manufacturer. The customer was educated regarding using only manufacturer authorized parts and service.
 
Event Description
Dental assistant was using handpiece and the bur slipped out into the patient's mouth. The bur was swallowed. Patient was sent to hospital for x-rays but bur passed safely.
 
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Brand NameLARES RESEARCH
Type of DeviceHIGH-SPEED DENTAL HANDPIECE
Manufacturer (Section D)
LARES RESEARCH
295 lockheed avenue
chico CA 95973
MDR Report Key12694426
MDR Text Key281981313
Report Number2916440-2021-00004
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K141221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Replace
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number757 ULTRALITE
Device Catalogue Number10305-235
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2021
Is This a Reprocessed and Reused Single-Use Device? No

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