MAUDE Adverse Event Report: TTBIO CORP. HENRY SCHEIN; INSERT

Model Number	ACCLEAN EASY GRIP XL TRIPLE BEND SLIM #1000 30K
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Doctors hand was burned during use of device.

• Brand Name: HENRY SCHEIN
• Common Device Name: INSERT
• 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
• MDR Report Key: 20006488
• Report Number: 3010364969-2024-00015
• Device Sequence Number: 4376210
• Product Code: ELC
• UDI-Device Identifier: 00304040165126
• UDI-Public: 00304040165126
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: ACCLEAN EASY GRIP XL TRIPLE BEND SLIM #1000 30K
• Device Catalogue Number: 570-2237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown