MAUDE MDR 564025

MDR report key
564025
Report number
1020379-2004-00017
Event key
0
Event type
3
Date of event
2002-01-01
Date received
2005-01-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1500 LITTLETON RD. PARSIPPANY NJ 07054 US
Phone
973-973-9738
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POLIDENT DENTURE CLEANSER TABLETDENTURE CLEANSERGLAXOSMITHKLINE, US PRODUCT SAFETYJER**UNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-01-0501. O

Event Narratives#

D

Patient 1

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF DIFFICULTY WRITING IN A PT WHO USED POLIDENT (POLIDENT DENTURE CLEANSER TABLETS) FOR DENTAL CARE. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICATIONS INCLUDED POLIDENT OVERNIGHT DENTURE CLEANSER TABLETS. IN 2002 THE PT STARTED USING POLIDENT (DENTAL). IN 2002, THE PT EXPERIENCED DIFFICULTY WRITING, NEUROLOGICAL PROBLEMS, SLURRED SPEECH, INSTABILITY AND DIZZINESS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH POLIDENT WAS CONTINUED. THE EVENTS ARE UNRESOLVED. NO CORRECTIVE ACTIONS HAVE BEEN REQUIRED BASED ON THIS REPORT.