3M¿ PARADIGM¿ REGULAR BODY FAST SET VPS IMPRESSION MATERIAL
Received Sep 30, 2025 · Event occurred Sep 8, 2025
Report 3005174370-2025-00002 · MDR key 23183368
Device
Generic name
Material, Impression
Manufacturer
3m Espe Dental ProductsModel number
5515Catalog number
5515
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Obstruction/Occlusion
- Obstruction/Occlusion
Narrative
Additional Manufacturer Narrative
NO LOT NUMBER WAS PROVIDED AND NO SAMPLE WAS AVAILABLE; THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. SOLVENTUM CANNOT VERIFY THE IDENTITY OF THE ALLEGED MATERIAL THAT WAS SWALLOWED. MULTIPLE UNSUCCESSFUL ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE. SOLVENTUM WILL CONTINUE TO MONITOR.
Description of Event or Problem
AN ELDERLY PATIENT ALLEGEDLY SWALLOWED 3M¿ PARADIGM¿ REGULAR BODY FAST SET VPS IMPRESSION MATERIAL USED TO RELINE AN EXISTING DENTURE ABOUT A YEAR AGO. TWO SURGERIES WERE PERFORMED TO REMOVE THE MATERIAL. IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED DEMENTIA SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED.