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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 PROSTYLE SF
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/28/2023
Event Type  malfunction  
Event Description
Dr sent in device with note that a bur had come out during procedure.The bur was not swallowed by the paitent.
 
Manufacturer Narrative
The device was not well maintained and there was significant debris in the chucking mechanism which caused premature wear.
 
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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 Key17664696
MDR Text Key322435174
Report Number2916440-2023-00014
Device Sequence Number1
Product Code EFB
UDI-Device IdentifierD950131412220
UDI-PublicD950131412220
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Dentist
Remedial Action Repair
Type of Report Initial
Report Date 08/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number757 PROSTYLE SF
Device Catalogue Number13141-222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2020
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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