MAUDE Adverse Event Report: DENTSPLY LLC SMARTLITE PRO INTRO KIT; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Catalog Number	644400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In this event it is reported that smartlite pro intro kit overheating and causing hot sensation in patient's mouth.Reportedly, no injury.
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
Additional Manufacturer Narrative
We´ve checked at our equipment service.We didn't found any failure, not a complaint.Please see our service no.(b)(4).Entered in our database rms: in: 24.01.2024, out: 02.02.2024 failure mode : hot equipment - overheating root cause: no defect.Conclusion code: no failure found.

• Brand Name: SMARTLITE PRO INTRO KIT
• Common Device Name: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
• Manufacturer (Section D): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer (Section G): DENTSPLY LLC; 38 west clarke avenue; milford DE 19963
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18444399
• Report Number: 2515379-2023-00116
• Device Sequence Number: 7867310
• Product Code: EBZ
• UDI-Device Identifier: D0026444001
• UDI-Public: D0026444001
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K191865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 644400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/19/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown