MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY PREMIER NEXTEMP; TEMPORARY CEMENT

Model Number	3001470
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The adverse event occured to the dentist.No patients were impacted.Nextemp cement creates an exothermic reaction.The more cement used, the more heat would be generated.The amount the dentist applied to his finger is a substantially and significantly more than what would be applied to a tooth preparation.Therefore, the risk of pulp damage or increase sensitivity to nextemp cement is a nominal risk to the patient.
Event or Problem Description
Dentist applied nextemp cement to his gloved hand since patients have been more sensitive to temperatures recently.He reported that nextemp got extremely hot and had to rip his glove off due to pain from the heat.Dentist assumes that nextemp may be too hot on patients tooth preparation based on the adverse event which occured on his gloved hand.

• Brand Name: PREMIER NEXTEMP
• Common Device Name: TEMPORARY CEMENT
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): B.J.M. LABORATORIES LTD.; 12 hassadna st.; industrial park; or-yehuda central, 60220 11; IS 6022011
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 16727422
• Report Number: 2511556-2023-00002
• Device Sequence Number: 7226381
• Product Code: EMA
• UDI-Device Identifier: 00348783000207
• UDI-Public: 00348783000207
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

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 Expiration Date: 07/31/2024
• Device Model Number: 3001470
• Device Catalogue Number: 3001470
• Device Lot Number: 4237-23QTP
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown