MAUDE Adverse Event Report: TTBIO CORP BRASSELER BRIO 450L; HANDPIECE

Model Number BRIO 450L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Surgical bur came out of handpiece where patient swallowed the bur.

• Brand Name: BRASSELER BRIO 450L
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 18813113
• MDR Text Key: 336614538
• Report Number: 3007007357-2024-00003
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BRIO 450L
• Device Catalogue Number: 5027989U0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/29/2024
• Distributor Facility Aware Date: 02/05/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male