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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; 557 HIGH-SPEED HANDPIECE
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LARES RESEARCH LARES RESEARCH; 557 HIGH-SPEED HANDPIECE Back to Search Results
Model Number 557
Device Problems Unintended Ejection (1234); Activation, Positioning or Separation Problem (2906); Premature Separation (4045)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
Event Type  malfunction  
Event Description
During a dental procedure, the high-speed handpiece bur fell out of the handpiece into the patient's mouth.The bur was removed and not swallowed by patient.No other intervention was necessary.
 
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Brand Name
LARES RESEARCH
Type of Device
557 HIGH-SPEED 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 Key12278281
MDR Text Key265172654
Report Number2916440-2021-00003
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K780038
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 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number557
Device Catalogue Number10124-221
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2018
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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