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

Model Number ASPEN BRIO 440

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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.

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 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 ; TW 40755
• MDR Report Key: 16048946
• MDR Text Key: 306155639
• Report Number: 3010364969-2022-00009
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• 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
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female