3M ESPE RELYX ULTIMATE CEMENT
Received May 10, 2017 · Event occurred Apr 10, 2017
Report 9611385-2017-00006 · MDR key 6559273
Device
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
29 YR
- Syncope
- Dyspnea
- Patient Problem/Medical Problem
- Syncope
- Dyspnea
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
AT THE MOMENT IT IS NOT PROVEN THAT THE SYMPTOMS WERE DEFINITIVELY CAUSED BY THE DENTAL PRODUCTS AS NO FURTHER INFORMATION LIKE THE RESULTS OF AN ALLERGY TESTING ARE AVAILABLE. HOWEVER, THE TIMELY CORRELATION MAKES SUCH A COINCIDENCE POSSIBLE. THE PRODUCTS CONTAIN METHACRYLATES, WHICH CAN CAUSE ALLERGIES IN VERY RARE CASES. APPROPRIATE WARNINGS ARE PRESENT IN THE INSTRUCTIONS FOR USE AND IN THE SAFETY DATA SHEETS OF THE PRODUCTS. THIS EVENT INVOLVED TWO MEDICAL DEVICES, THEREFORE TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS DEVICE DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBER 9611385-2017-00005 DESCRIBES THE FIRST DEVICE.
Description of Event or Problem
ON (B)(6) 2017, 3M WAS NOTIFIED THAT A (B)(6) FEMALE PATIENT EXPERIENCED A POTENTIAL ALLERGIC REACTION FOLLOWING A DENTAL TREATMENT WHICH INCLUDED 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT. THE POTENTIAL ALLERGIC REACTION OCCURRED AT 09.30 A.M. ON (B)(6) 2017 SHORTLY AFTER THE DENTAL TREATMENT. THE SYMPTOMS WERE NO FEELING IN LIPS AND HAND, SHORTNESS OF BREATH AND WHEEZING, AND THE PATIENT WAS LOSING CONSCIOUSNESS. PARAMEDICS WERE CALLED AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. IT WAS REPORTED THAT THAT PATIENT RECEIVED TWO ADRENALINE NEBULIZER TREATMENTS. THE PATIENT FULLY RECOVERED BY 5 P.M. ON THE SAME DAY. OTHER DENTAL PRODUCTS, INCLUDING LOCAL ANESTHETICS, WERE ALSO USED DURING THE DENTAL TREATMENT.