MAUDE Adverse Event Report: TTBIO CORPORATION BRIO 440; HANDPIECE

Model Number BRIO 440

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2021

Event Type  Injury  

Event Description

During finishing/polishing of #15 filling, bur came out of handpiece.Told patient not to move or swallow.Attempted to fish out bur but patient swallowed before dentist could remove bur.Explained what happened and strongly recommended going to er.Gave patient note for the doctor and business card.Patient stated he felt fine and will go to doctor after appointment.Completed extractions that were initiated.Stabilized patient and sent to er.Patient was happy about completing dental treatment and understands situation.

Event Description

During finishing/polishing of #15 filling, bur came out of handpiece.Told patient not to move or swallow.Attempted to fish out bur but patient swallowed before dentist could remove bur.Explained what happened and strongly recommended going to er.Gave patient note for the doctor and business card.Patient stated he felt fine and will go to doctor after appointment.Completed extractions that were initiated.Stabilized patient and sent to er.Patient was happy about completing dental treatment and understands situation.

• Brand Name: BRIO 440
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORPORATION; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: kevin lin ; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• MDR Report Key: 13556944
• MDR Text Key: 285809059
• Report Number: 3010364969-2022-00003
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BRIO 440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male