MAUDE Adverse Event Report: TTBIO CORP ASPEN BRIO 440; HANDPIECE

Model Number ASPEN BRIO 440

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2022

Event Type  Injury  

Event Description

Doctor was using the handpiece when the bur came off in the patient's mouth and was swallowed.

• Brand Name: ASPEN BRIO 440
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 15905713
• MDR Text Key: 304707700
• Report Number: 3007007357-2022-00015
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00810988030391
• UDI-Public: 00810988030391
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASPEN BRIO 440
• Device Catalogue Number: 9076252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2022
• Distributor Facility Aware Date: 11/04/2022
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female