3M¿ RELYX¿ UNICEM 2 AUTOMIX SELF-ADHESIVE RESIN CEMENT
Received Mar 13, 2025 · Event occurred Feb 11, 2025
Report 3008512935-2025-00001 · MDR key 21594475
Device
Generic name
Cement, Dental
Manufacturer
3m Deutschland GmbhModel number
56848Catalog number
56848
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Anaphylactoid / Anaphylaxis
- Anaphylactoid / Anaphylaxis
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO SOLVENTUM FOR ANALYSIS AND NO LOT NUMBER WAS PROVIDED. COMPLAINTS WERE REVIEWED WITH NO ADVERSE TREND OBSERVED. SOLVENTUM WILL CONTINUE TO MONITOR.
Description of Event or Problem
A DENTIST REPORTED A PERMANENT CROWN WAS PLACED, AND THE PATIENT'S THROAT BECAME DRY AND SWOLLEN, HANDS WERE ITCHY, AND IT WAS HARD TO TALK. THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY ROOM AND RECEIVED AN EPINEPHRINE INJECTION, STEROIDS, AND ALLERGY MEDICINE. IT WAS NOT REPORTED WHEN THE PATIENT STARTED TO DEVELOP THE SYMPTOMS IN CORRELATION TO HER CROWN PLACEMENT. SYMPTOMS IMPROVED AFTER SHE TOOK THE STEROIDS.