3M¿ RELYX¿ UNICEM 2 AUTOMIX SELF-ADHESIVE RESIN CEMENT
Received Dec 30, 2025 · Event occurred Sep 9, 2025
Report 3008512935-2025-00006 · MDR key 23931002
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
BASED ON THE INFORMATION PROVIDED, IT COULD NOT BE DETERMINED THAT THE ALLEGED ALLERGIC REACTION IS RELATED TO THE 3M¿ RELYX¿ UNICEM 2 AUTOMIX SELF-ADHESIVE RESIN CEMENT. A PRODUCT QUALITY INVESTIGATION IS PENDING COMPLETION.
Description of Event or Problem
ON (B)(6) 2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE DENTIST: ON (B)(6) 2025, A PATIENT HAD A CROWN AND BRIDGE PLACED ON RIGHT-SIDE USING 3M¿ RELYX¿ UNICEM 2 AUTOMIX SELF-ADHESIVE RESIN CEMENT. WITHIN THREE HOURS AFTER THE APPOINTMENT, THE PATIENT EXPERIENCED FULL FACIAL SWELLING AND HIVES IN THE AREA OF THE BRIDGE. PATIENT WENT TO THE EMERGENCY ROOM THE SAME DAY AND WAS TREATED WITH EPINEPHRINE. PATIENT HAS BEEN TO THE EMERGENCY ROOM TWICE FOR THIS ISSUE AND HAS TO TAKE BENADRYL DAILY TO PREVENT AND ALLEVIATE RETURN OF SYMPTOMS. THE PATIENT HAS A KNOWN ALLERGY TO SHELLFISH.