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

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.

• Brand Name: LARES RESEARCH
• Type of Device: HIGH-SPEED DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• MDR Report Key: 12694426
• MDR Text Key: 281981313
• Report Number: 2916440-2021-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K141221
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 757 ULTRALITE
• Device Catalogue Number: 10305-235
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Date Manufacturer Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR