MAUDE Adverse Event Report: TTBIO CORP. ACCLEAN ULTRASONIC SCALER

Model Number ACCLEAN ULTRASONIC SCALER

Device Problem Insufficient Information (3190)

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

Event Date 02/21/2023

Event Type  Injury  

Event Description

During a routine prophy with some scaling and cavitron use, the black handpiece where the cavitron tip is inserted caused a pizza like burn to the right inside part of patient's mouth.

• Brand Name: ACCLEAN ULTRASONIC SCALER
• Type of Device: SCALER
• 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: 16652810
• MDR Text Key: 312405400
• Report Number: 3010364969-2023-00001
• Device Sequence Number: 1
• Product Code: EFB
• 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: Other
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACCLEAN ULTRASONIC SCALER
• Device Catalogue Number: 9076252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 25 YR
• Patient Sex: Female