POLIGRIP PASTE *

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 2004-03-05 for POLIGRIP PASTE * manufactured by Glaxosmithkline Consumer Healthcare, Med Affairs, Us Product Safety.

Event Text Entries

[335643] This case was reported by a consumer's family member and described the occurrence of "vasculitis" in a consumer who used an unspecified variant of super poligrip denture adhesive cream. The consumer initially called to inquire whether or not it is safe to ingest a small amount of the product. A physician or other health care professional has not verified this report. The consumer's family member reported that the consumer began using super poligrip denture adhesive cream for their dentures just over five years ago. Family member also reported that although the consumer used super poligrip as directed on the package, consumer would sometimes accidentally ingest a small amount of the product. The consumer's family member reported that the product worked well for the consumer and about two weeks ago, the consumer began to notice two or three blisters on their right foot. The consumer's family member reported that due to the event, the consumer was taken to see a physician, who thought it was an infection. The consumer's family member reported that the physician did not drain the blisters but he treated them with an unknown antibiotic cream. The consumer's family member reported that the antibiotic did not seem to help the symptoms and about four days later, the blisters became worse and it spread to the consumer's right ankle. The consumer's family member reported that the consumer was taken to the physician again and he admitted consumer to a hosp for tests. Cat scan, a complete blood test and an mri, for which all of the results were negative. The consumer's family member reported that the consumer underwent these tests to rule out cancer. The specific details of the cat scan or the mri are unknown. The reason for the physician to perform tests to rule out cancer or the type of cancer he suspected is unknown. The consumer's family member reported that the consumer was diagnosed with "vasculitis" secondary to a "blood vessel infection" and consumer was treated with unknown oral and topical antibiotics, oral prednisone and ranitidine (zantac). Family member reported that the consumer's symptoms improved. The next day consumer was discharged from the hosp within about five days with instructions to apply the antibiotic cream and warm compress on the blisters. The consumer's family member reported that the physician was made aware of all of the consumer's medications and products, including the use of super poligrip denture adhesive cream, but the physician could not determine the cause of their symptoms. The consumer's family member reported that currently, the consumer is still using super poligrip denture adhesive cream and that the blisters on their foot and ankle have completely resolved. The consumer's family member further reported that the consumer has a 10-year history of osteoporosis, a 30-year history of asthma and a 30-year history of smoking one pack of cigarettes per day. Family member also reported that the consumer has been taking one alendronate (fosamax) every week for about 10 years and consumer has also been using oxygen as needed for asthma for about 20 years. The consumer's family member refused to grant the mfr permission to contact the consumer's physician. The consumer's family member did not know the exact variant, the lot number or the expiration date of the product and family member refused to grant the mfr permission to contact the consumer to obtain the product info. The consumer's family member was advised that ingredients of this product are edible and non-toxic and swallowing small amounts of this product during normal usage is expected and is not harmful. The consumer's family member agreed that if family member thought that the consumer was swallowing an unusually large amount of the product, they would contact the consumer's dentist about the fit of their dentures.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2004-00001
MDR Report Key515005
Report Source04
Date Received2004-03-05
Date of Report2004-03-05
Date of Event2004-01-01
Date Mfgr Received2004-02-04
Date Added to Maude2004-03-11
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 ROAD
Manufacturer CityPARSIPPANY NJ 070543884
Manufacturer CountryUS
Manufacturer Postal070543884
Manufacturer Phone9738892494
Manufacturer G1GLAXOSMITHKLINE, IRELAND
Manufacturer StreetYOUGHAL ROAD CLOCHERANE
Manufacturer CityDUNGARVAN, COUNTY WATERFORD
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLIGRIP PASTE
Generic NameDENTURE ADHESIVE
Product CodeKOP
Date Received2004-03-05
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 Key504012
ManufacturerGLAXOSMITHKLINE CONSUMER HEALTHCARE, MED AFFAIRS, US PRODUCT SAFETY
Manufacturer Address1500 LITTLETON ROAD PARSIPPANY NJ 07054 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2004-03-05

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