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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 557 PROSTYLE SF SLC
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2023
Event Type  malfunction  
Manufacturer Narrative
The device was tested by the manufacturer and it operated as intended.
 
Event Description
Device head became hot and made a loud high pitch after lubrication.
 
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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 Key16710132
MDR Text Key313235494
Report Number2916440-2023-00008
Device Sequence Number1
Product Code EFB
UDI-Device IdentifierD950131242360
UDI-Public+D950131242360
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 Replace
Type of Report Initial
Report Date 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number557 PROSTYLE SF SLC
Device Catalogue Number13124-236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2023
Initial Date FDA Received04/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2023
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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