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 Laceration(s) (1946)

Event Type  malfunction  

Event Description

Surgical bur came out of handpiece where patient was cut inside the cheek.

• Brand Name: BRASSELER BRIO 450L
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f., no.7, 6th road; industry park; taichung, 40755
• MDR Report Key: 19030093
• MDR Text Key: 339219823
• Report Number: 3010364969-2024-00004
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00887919872283
• UDI-Public: 0100887919872283
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/03/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female