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

Model Number 3001470

Device Problem Improper Chemical Reaction (2952)

Patient Problem Burning Sensation (2146)

Event Date 03/21/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 313163635
• Report Number: 2511556-2023-00002
• Device Sequence Number: 1
• Product Code: EMA
• UDI-Device Identifier: 00348783000207
• UDI-Public: 00348783000207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3001470
• Device Catalogue Number: 3001470
• Device Lot Number: 4237-23QTP
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other