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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TTBIO CORP. BRIO 440; HANDPIECE
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TTBIO CORP. BRIO 440; HANDPIECE Back to Search Results
Model Number BRIO 440
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
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 feels fine and will go to doctor after today's appointment.Completed extractions that were initiated.Stabilized patient and sent to er.Patient was happy about completing dental treatment and understands.
 
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Brand Name
BRIO 440
Type of Device
HANDPIECE
Manufacturer (Section D)
TTBIO CORP.
2f, no.7, 6th road industry pa
taichung 40755
TW  40755
MDR Report Key13510629
MDR Text Key287191975
Report Number3007007357-2022-00002
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 02/11/2022,02/08/2022
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 NumberBRIO 440
Device Catalogue Number570-0486
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2022
Distributor Facility Aware Date01/12/2022
Device Age3 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/11/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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