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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLAXOSMITH KLINE CONSUMER HEALTH LP POLIGRIP DENTURE CREAM ; ADHESIVE,DENTURE,CARBOSYMETHYLCELLULOSE SODIUM(32%) AND ETHYLENE-OXIDE HOMOPOLY
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GLAXOSMITH KLINE CONSUMER HEALTH LP POLIGRIP DENTURE CREAM ; ADHESIVE,DENTURE,CARBOSYMETHYLCELLULOSE SODIUM(32%) AND ETHYLENE-OXIDE HOMOPOLY Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problems Headache (1880); Pain (1994); Visual Impairment (2138); Sleep Dysfunction (2517); Patient Problem/Medical Problem (2688)
Event Date 08/16/2019
Event Type  No Answer Provided  
Event Description
Case# (b)(4); dear sir, i have been trying to get some advice from someone to help me with my situation.On (b)(6) 2019 i used polygrip denture cream before i went to bed and i woke up around 2:30am with the most god awful taste and odor in my mouth and i had drooled some out, "the cream side of my face", and made me want to vomit, but i took my denture out and brushed them with closeup toothpaste and i gargled with mouthwash.That night i had a headache and i was so nervous i could not sleep.It tasted like it had human feces in it, and i think the person who did this should be punished and that polygrip should be made to seal the tube from now on.Enclosed is a page stating how many times i called, and i don't know what to do, so that is why i am writing to fda to see if you can help me.Thank you very much, i want to know what is in the tube that i brought.My vision, and my joints are hurting me now.I will wait for your call.I am (b)(6) and don't know how to take messages or type, so please call me until you get me on the phone.
 
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Brand Name
POLIGRIP DENTURE CREAM
Type of Device
ADHESIVE,DENTURE,CARBOSYMETHYLCELLULOSE SODIUM(32%) AND ETHYLENE-OXIDE HOMOPOLY
Manufacturer (Section D)
GLAXOSMITH KLINE CONSUMER HEALTH LP
MDR Report Key9711652
MDR Text Key180123182
Report NumberMW5093008
Device Sequence Number1
Product Code KOL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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