KETAC CEM PLUS AUTOMIX
Received Jun 8, 2016
Report 3005174370-2016-00062 · MDR key 5707666
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Anaphylactic Shock
- Patient Problem/Medical Problem
- Anaphylactic Shock
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
THE PRODUCT CONTAINS AN INGREDIENT WHICH CAN TRIGGER AN ALLERGIC REACTION IN THOSE INDIVIDUALS WHO ARE PRE-SENSITIZED TO SULFITES. THE IFU CONTAINS INFORMATION REGARDING THIS CROSS-REACTION. IT IS ALSO UNCLEAR, WHY THE PRODUCT WAS USED ON THIS PATIENT A SECOND TIME AFTER A REACTION WAS NOTED. BECAUSE NO ORIGINAL MATERIAL OR BATCH-NOS. WERE SENT TO US, NO FURTHER INVESTIGATION ON THE ORIGINAL MATERIAL OR A RETAINED SAMPLE COULD BE PERFORMED. THIS PRODUCT HAS BEEN EVALUATED FOR BIOCOMPATIBILITY AND FOUND TO BE SAFE FOR ITS INTENDED USE; FURTHER, IT HAS A FAVORABLE CLINICAL USE PROFILE WITH NO OTHER REPORTS OF THIS NATURE OCCURING THIS YEAR.
Description of Event or Problem
3M (B)(4) WAS INFORMED ON MAY 9TH, 2016, ABOUT A MEDICAL COMPLAINT INVOLVING THE 3M ESPE RELYX LUTING PLUS AUTOMIX (ALSO KNOWN AS KETAC CEM PLUS AUTOMIX). IT WAS REPORTED BY A HOSPITAL THAT A PATIENT EXPERIENCED ANAPHYLACTIC SHOCK TWICE AFTER THE USE OF THE PRODUCT. ACCORDING TO THE REPORTER, THE ROOT CAUSE FOR THE EVENT WAS AN ALLERGY, BUT IT WAS NOT SPECIFIED WHICH SUBSTANCE CAUSED THE SYMPTOMS. DESPITE SEVERAL ATTEMPTS, THE HOSPITAL REFUSED TO PROVIDE FURTHER INFORMATION, SO NO ADDITIONAL INFORMATION IS AVAILABLE.