RELYX LUTING LUTING CEMENT
Received Dec 21, 2015 · Event occurred Oct 13, 2015
Report 3005174370-2015-00131 · MDR key 5317238
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Itching Sensation
- Occlusion
- Rash
- Swelling
- Loss of consciousness
Narrative
Additional Manufacturer Narrative
ENGINEERING INVESTIGATION WAS LIMITED DUE TO LACK OF RETURNED PRODUCT AND LOT NUMBER INFORMATION. THE ROLE THAT THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS AND SEVERAL CONCURRENT MEDICATIONS MAY HAVE PLAYED IN THIS CASE IS UNKNOWN. IN THE UN-CURED STATE, THIS PRODUCT CONTAINS METHACRYLATE RESINS WHICH CAN TRIGGER AN ALLERGIC REACTION IN INDIVIDUALS WITH SENSITIVITIES TO ACRYLIC-BASED MATERIALS, WHICH THIS PATIENT REPORTS. THIS PRODUCT ALSO CONTAINS POTASSIUM PERSULFATE, WHICH CAN TRIGGER AN ALLERGIC RESPIRATORY REACTION IN CERTAIN INDIVIDUALS. INFORMATION ABOUT THESE POTENTIAL REACTIONS ARE ALREADY PROVIDED IN THE PRODUCT INSTRUCTIONS FOR USE.
Description of Event or Problem
A PATIENT EXPERIENCED AN ALLERGIC-TYPE REACTION AFTER SIX CROWNS WERE CEMENTED WITH 3M ESPE RELYX LUTING CEMENT ON (B)(6) 2015. WITHIN TWO HOURS, THE PATIENT NOTICED LOWER LIP SWELLING AND ITCHY BLOTCHES ON HER CHIN. THE REACTION PROGRESSED AND ON (B)(6) 2015, THE PATIENT EXPERIENCED THROAT TIGHTNESS, FELT OUT OF BALANCE, AND LOST CONSCIOUSNESS. THE PATIENT GAVE HERSELF AN INJECTION WITH EPIPEN(R) AND CALLED 911; HOWEVER, WHEN PARAMEDICS ARRIVED SHE HAD IMPROVED AND REQUESTED THAT SHE NOT BE TRANSPORTED. ABOUT 2-3 HOURS LATER, THE PATIENT DEVELOPED RECURRING SWELLING BENEATH HER CHIN AND SHORTNESS OF BREATH; PATIENT SOUGHT HELP AT AN EMERGENCY ROOM. IN THE ER, THE PATIENT WAS ADMINISTERED PREDNISONE, BENADRYL, AND MORE EPINEPHRINE. THE PATIENT WAS REFERRED TO AN ALLERGIST WHO PRESCRIBED ZYRTEC (ANTIHISTAMINE) FOR THE HIVES AND ITCHING, A HYDROCORTISONE CREAM FOR THE RASH, AND AN EPIPEN IN CASE THE REACTION REOCCURS. THE ALLERGIST ALSO STATED THAT THE PATIENT MAY HAVE A SENSITIVITY TO POTASSIUM PERSULFATE, A COMPONENT OF THE SUBJECT CEMENT. THE TREATING DENTIST HAS VOLUNTEERED TO REMOVE HER CROWNS IF THE PATIENT'S REACTION IS DETERMINED BY THE ALLERGIST TO BE THE RESULT OF THE SUBJECT CEMENT; HOWEVER, THE DENTIST REPORTED HE DOES NOT FEEL IT IS RELATED TO THE CEMENT SINCE THE PATIENT'S INTRA-ORAL EXAM SHOWED NO ISSUES; SOFT TISSUE LOOKED HEALTHY UPON PLACEMENT. THE DENTIST ALSO STATED THAT HE DOES NOT FEEL IT IS DUE TO THE ACRYLATES IN THE CEMENT SINCE HE PLACED A TEMPORARY RESTORATION WITH AN ACRYLIC CEMENT PREVIOUSLY AND SAW NO REACTION. THE PATIENT WAS REPORTED BY THE DENTIST TO BE "VIRTUALLY ASYMPTOMATIC" ON (B)(6) 2015.