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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 ULTRALIGHT
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
Doctor stepped on footpedal to start handpiece and the handpiece came apart.The handpiece was not near a patient so the paitent was not injured.
 
Manufacturer Narrative
Product was sent back to the factory disassembled.Evaluation of the components identifed possible missing components during operation and vibration.Exact cause of failue not established.
 
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Brand Name
LARES RESEARCH
Type of Device
HIGH-SPEED DENTAL HANDPIECE
Manufacturer (Section D)
LARES RESEARCH
295 lockheed avenue
chico CA 95973
Manufacturer (Section G)
LARES RESEARCH
295 lockheed avenue
chico CA 95973
Manufacturer Contact
bruce holderbein
295 lockheed avenue
chico, CA 95973
5303451767
MDR Report Key13905389
MDR Text Key289106535
Report Number2916440-2022-00003
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K905541
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 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number757 ULTRALIGHT
Device Catalogue Number10305-235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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