InjuryEMA

NEXTEMP

Received May 21, 2025 · Event occurred Apr 18, 2025

Report 2511556-2025-00002 · MDR key 22060816

Device

Generic name

Cement, Dental

Manufacturer

Premier Dental Products Company

Catalog number

3001471

Lot number

4282-01QT

Product problems

Adverse Event Without Identified Device or Use Problem
Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

Hemorrhage/Blood Loss/Bleeding
Burning Sensation
Skin Inflammation/ Irritation
Hemorrhage/Blood Loss/Bleeding
Burning Sensation
Skin Inflammation/ Irritation

Narrative

Description of Event or Problem

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.