MAUDE Adverse Event Report: PRIMA DENTAL GROUP HENRY SCHEIN; CARBIDE SURGICAL BUR FG 557

Catalog Number 100-8502

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2022

Event Type  Injury  

Event Description

The dentist was performing a procedure on a 64 year old male patient when the bur came out of a handpiece and was swallowed by the patient.Abdominal radiographs were done initially and ct scan at a later date to make sure the bur passed the stool.

• Brand Name: HENRY SCHEIN
• Type of Device: CARBIDE SURGICAL BUR FG 557
• Manufacturer (Section D): PRIMA DENTAL GROUP; stephenson drive waterwells; business park; gloucester, GL2 2 HA; UK GL2 2HA
• MDR Report Key: 14349579
• MDR Text Key: 294161879
• Report Number: 2411236-2022-00002
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2022,04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 100-8502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2022
• Distributor Facility Aware Date: 04/26/2022
• Event Location: Other
• Date Report to Manufacturer: 05/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male