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

Catalog Number	3001471
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The dentist and his team used nextemp on the patient for two weeks.The patient's tissue appeared red, irriated, and bleeding when the patient returned to the office.

• Brand Name: NEXTEMP
• Common Device Name: CEMENT, DENTAL
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting PA 19462
• Manufacturer (Section G): B.J.M. LABORATORIES LTD; 12 hasadna st.; industrial park; or-yehuda, 60220 11; IS 6022011
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting 19462 ; 6102396069
• MDR Report Key: 22060816
• Report Number: 2511556-2025-00002
• Device Sequence Number: 20795750
• Product Code: EMA
• UDI-Device Identifier: 00348783000214
• UDI-Public: 00348783000214
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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
• Device Expiration Date: 01/26/2026
• Device Catalogue Number: 3001471
• Device Lot Number: 4282-01QT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 05/21/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown