MAUDE Adverse Event Report: MONITEX INDUSTRIAL CO. LTD. HENRY SCHEIN; CURING LIGHT

Model Number	MAXIMA ADVANCED 3000 LED
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The curing light gets too hot and burned a patient during a procedure.

• Brand Name: HENRY SCHEIN
• Common Device Name: CURING LIGHT
• Manufacturer (Section D): MONITEX INDUSTRIAL CO. LTD.; 5f, 70, sec. 1, guangfu road.,; sanchong dist.,, new taipei 241 ; TW 241
• MDR Report Key: 24097131
• Report Number: 3007007357-2026-00001
• Device Sequence Number: 21431736
• Product Code: EBZ
• UDI-Device Identifier: 00304040186008
• UDI-Public: (01)00304040186008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2026
• Report Date (Section F): 01/16/2026

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: MAXIMA ADVANCED 3000 LED
• Device Catalogue Number: 570-3853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2025
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/16/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/16/2026