POLIDENT DENTURE CLEANSER TABLET *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-01-05 for POLIDENT DENTURE CLEANSER TABLET * manufactured by Glaxosmithkline, Us Product Safety.

Event Text Entries

[313870] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020379-2004-00017
MDR Report Key564025
Report Source04
Date Received2005-01-05
Date of Report2005-01-04
Date of Event2002-01-01
Date Mfgr Received2004-12-09
Date Added to Maude2005-01-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street1500 LITTLETON RD.
Manufacturer CityPARSIPPANY NJ 07054
Manufacturer CountryUS
Manufacturer Postal07054
Manufacturer Phone9738892494
Manufacturer G1GLAXOSMITHKLINE MEMPHIS FACILITY
Manufacturer Street2149 HARBOR AVE.
Manufacturer CityMEMPHIS TN 36113
Manufacturer CountryUS
Manufacturer Postal Code36113
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLIDENT DENTURE CLEANSER TABLET
Generic NameDENTURE CLEANSER
Product CodeJER
Date Received2005-01-05
Model Number*
Catalog Number*
Lot NumberUNK
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key553759
ManufacturerGLAXOSMITHKLINE, US PRODUCT SAFETY
Manufacturer Address* PARSIPPANY NJ 07054 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-01-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.