3M ESPE POLYETHER ADHESIVE
Received Aug 7, 2013 · Event occurred May 22, 2013
Report 9611385-2013-00013 · MDR key 3310620
Device
Product problems
- Device Operates Differently Than Expected
Patient
43 YR
- Skin Discoloration
- Swelling
- Numbness
Narrative
Additional Manufacturer Narrative
AS NOTED IN THE EVENT DESCRIPTION OF THIS REPORT, THREE SUSPECT DEVICES WERE INVOLVED IN THE CURRENT EVENT, THEREFORE, THIS REPORT INCLUDES THE THIRD SUSPECT DEVICE AND THE OTHER TWO SUSPECT DEVICE DESCRIPTIONS ARE INCLUDED IN MFR REPORT NUMBERS 9611385-2013-00011 AND 9611385-2013-00012, RESPECTIVELY. THE SUSPECT DEVICE NOTED IN THIS REPORT HAS NOT BEEN RETURNED TO 3M ESPE. THE ANALYSIS OF A RETAINED SAMPLE OF THE SAME LOT SHOWED NO PARTICULARITY. THIS PRODUCT HAS BEEN ASSESSED FOR BIOCOMPATIBILITY AND HAS BEEN FOUND TO BE SAFE FOR ITS INTENDED USE. THE DENTIST STATED THAT THERE WAS ALREADY AN INTOLERANCE REACTION WHEN THE PRODUCTS WERE APPLIED TO THE PT IN THE YR 1996, BUT AT THIS TIME THERE WERE ONLY MILD SYMPTOMS. THEREFORE, IT CAN BE ASSUMED, THAT THERE'S UNDERLYING ALLERGIC REACTION. THIS TIME THE SYMPTOMS WERE ALSO NOT LIFE-THREATENING, BUT RATED AS SEVERE BY THE DENTIST.
Description of Event or Problem
AFTER A DENTAL IMPRESSION USING THE 3M ESPE PRODUCTS 3M ESPE PERMADYNE H, 3M ESPE PERMADYNE L, AND 3M ESPE POLYETHER ADHESIVE A PT SUFFERED FROM STRONG SWELLING AND REDDENING IN THE AREAS OF THE NECK AND THE CHEEKS. ADDITIONALLY SHE HAD A NUMB FEELING IN THE TONGUE. ALL SYMPTOMS VANISHED AFTER THREE DAYS. THE SYMPTOMS WERE RATED SERIOUS BY THE DENTIST.