MAUDE MDR 4877676

MDR report key
4877676
Report number
9681138-2015-00033
Event key
0
Event type
3
Date received
2015-06-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
P.O. BOX 13398 RESEARCH TRIANGLE PARK NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COREGA ULTRA CREAM WITHOUT FLAVORDENTURE ADHESIVEGLAXOSMITHKLINE DUNGARVAN LTD.KOLR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-2901. D; 2. O

Event Narratives#

D

Patient 1

DEATH (UNKNOWN CAUSE) [UNKNOWN CAUSE OF DEATH]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF DEATH (UNKNOWN CAUSE) IN A (B)(6) MALE PATIENT WHO RECEIVED TRIPLE SALE DENTAL ADHESIVE CREAM (COREGA ULTRA CREAM WITHOUT FLAVOR) CREAM FOR ORAL PROTHESIS FIXATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA ULTRA CREAM WITHOUT FLAVOR. THE PATIENT EXPERIENCED DEATH (UNKNOWN CAUSE) (SERIOUS CRITERIA DEATH, GSK MEDICALLY SIGNIFICANT AND OTHER: GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE DEATH (UNKNOWN CAUSE) WAS FATAL. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEATH (UNKNOWN CAUSE) TO BE RELATED TO COREGA ULTRA CREAM WITHOUT FLAVOR. CASE REPORTED BY DISTRIBUTOR (INITIALLY ON (B)(6) 2014). PATIENT USED COREGA ADHESIVE CREAM DUE TO PROTHESIS FIXATION. RELATIVE REPORTED THAT PATIENT DIED DUE TO (UNKNOWN CAUSE). SHE DOES NOT GIVE MORE INFORMATION AND THERE'S NO AUTHORIZATION TO CONTACT PHYSICIAN. CASE WAS CONSIDERED CLOSED. CASE ORIGINALLY REPORTED AS A POST-MARKETING SURVEILLANCE CASE. FOLLOW UP INFORMATION WAS RECEIVED ON 10/13/2014. THIS CASE IS A SPONTANEOUS CASE REPORTED THROUGH A DISTRIBUTOR WHO HAS ALSO A CALL CENTER.