MAUDE Adverse Event Report: PRIMA DENTAL GROUP HENRY SCHEIN; CARBIDE BUR T&F 12 BLADE FG

Catalog Number 900-4370

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2021

Event Type  Injury  

Event Description

The dentist was performing a procedure on a male patient when the multi-fluted bur came out of the highspeed handpiece and the patient had swallowed it.The patient was advised to go to the emergency room.

• Brand Name: HENRY SCHEIN
• Type of Device: CARBIDE BUR T&F 12 BLADE FG
• Manufacturer (Section D): PRIMA DENTAL GROUP; stephenson drive waterwells; business park; gloucester, GL2 2 HA; UK GL2 2HA
• MDR Report Key: 13005638
• MDR Text Key: 287283031
• Report Number: 2411236-2021-00004
• Device Sequence Number: 1
• Product Code: EJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/14/2021,11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 900-4370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2021
• Distributor Facility Aware Date: 11/17/2021
• Event Location: Other
• Date Report to Manufacturer: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male