POLGRIP *

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 2004-04-14 for POLGRIP * manufactured by Glaxosmithkline Consumer Healthcare/med Affairs, Us Product Safety.

Event Text Entries

[320734] Consumer described the occurrence of endocarditis in a pt who received poligrip (super poligrip free denture adhesive cream) for loose dentures. A physician or other health care professional has not verified this report. The consumer, a long time user of the super poligrip free, reportedly developed ulcers on their tongue that consumer later described as mouth sores, could not eat for six days and felt awful after using the new formula of super poligrip free. The consumer discontinued product use a few days after symptom onset. The consumer saw their doctor for mouth sores and was reportedly diagnosed with a candida infection. Consumer was treated with diflucan. The consumer reported told their doctor about their use of super poligrip free but that their doctor did not know much about the product or if it was related to their candida infection. Follow-up information was received from the consumer in 03/2004. The consumer, with a history of carotid disease, reported that consumer was previously scheduled for a carotid endarterectomy before their candida infection. They reported that while hospitalized for the procedure, in july 2003 consumer experienced a high fever that was found to be from endocarditis. Consumer reported that an infectious disease doctor, upon hearing their history of mouth sores, reportedly told them that their endocarditis from streptococcus veridans was from their mouth sores. Consumer reported that after discharge from the hospital, consumer continued to receive rocephin, intravenously, every day for six weeks. After that, consumer reported taking keflex by mouth.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2004-00006
MDR Report Key523768
Report Source04
Date Received2004-04-14
Date of Report2004-04-14
Date Mfgr Received2004-03-15
Device Manufacturer Date2003-04-01
Date Added to Maude2004-05-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street1500 LITTLETON RD
Manufacturer CityPARSIPPANY NJ 070543884
Manufacturer CountryUS
Manufacturer Postal070543884
Manufacturer Phone9738892494
Manufacturer G1GLAXOSMITHKLINE, IRELAND
Manufacturer StreetCLOHERANE YOUGHAL RD
Manufacturer CityDUNGARVIN
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLGRIP
Generic NameDENTURE ADHESIVE
Product CodeKOP
Date Received2004-04-14
Returned To Mfg2003-06-13
Model Number*
Catalog Number*
Lot NumberR03101
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key512896
ManufacturerGLAXOSMITHKLINE CONSUMER HEALTHCARE/MED AFFAIRS, US PRODUCT SAFETY
Manufacturer Address1500 LITTLETOWN ROAD PARSIPPANY NJ 070543884 US


Patients

Patient NumberTreatmentOutcomeDate
1111. Hospitalization 2004-04-14

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