MAUDE MDR 5145103

MDR report key
5145103
Report number
3003721894-2015-00011
Event key
0
Event type
3
Date received
2015-09-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
PO 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
1POLIDENT DENTURE ADHESIVE CREAMDENTURE ADHESIVEGLAXOSMITHKLINE DUNGARVAN LTDKOLR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-2801. O

Event Narratives#

D

Patient 1

DEVICE DEPENDENCE [DEPENDENCE]. POSSIBLE DEVICE INGESTION [ACCIDENTAL DEVICE INGESTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF DEPENDENCE IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (POLIDENT DENTURE ADHESIVE CREAM) CREAM FOR DENTURE WEARER. ADDITIONAL PATIENT NOTES INCLUDED SHE HAD NO ALLERGY OR OTHER DISEASE HISTORY. IN 2013, THE PATIENT STARTED POLIDENT DENTURE ADHESIVE CREAM. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING POLIDENT DENTURE ADHESIVE CREAM, THE PATIENT EXPERIENCED DEPENDENCE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE DEPENDENCE WAS NOT RECOVERED/NOT RESOLVED AND THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE DEPENDENCE AND ACCIDENTAL DEVICE INGESTION TO BE RELATED TO POLIDENT DENTURE ADHESIVE CREAM. ADDITIONAL INFORMATION: THE CONSUMER USED POLIDENT CREAM FOR ONE OR TWO YEARS (AROUND 2013). THE PATIENT USED IT BEFORE EACH MEAL (3 TIMES DAILY) BECAUSE SHE FELT THE CREAM WAS WASHED AWAY AFTER MEAL. THE PATIENT DARED NOT TO EAT FOOD IF NOT USING THE CREAM, AND FELT THAT SHE DEVELOPED DEPENDENCE ON IT. THE PATIENT HAD CANCER SCREEN AND CONFIRMED NO CANCER DISEASE A FEW DAYS AGO.