FDA.reportPublic FDA data

MAUDE MDR 5707666

MDR report key
5707666
Report number
3005174370-2016-00062
Event key
0
Event type
3
Date received
2016-06-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANGIE DRAPER
Address
2510 CONWAY AVENUE ST. PAUL MN 55144 US
Phone
651-651-6517
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KETAC CEM PLUS AUTOMIXDENTAL CEMENT3M ESPE DENTAL PRODUCTSEMA3536R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-0801. O

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.