POLIGRIP DENTURE CREAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for POLIGRIP DENTURE CREAM manufactured by Glaxosmith Kline Consumer Health Lp.

Event Text Entries

[180123182] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093008
• MDR Report Key: 9711652
• Date Received: 2020-02-13
• Date of Report: 2020-02-13
• Date of Event: 2019-08-16
• Date Added to Maude: 2020-02-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: POLIGRIP DENTURE CREAM
• Generic Name: ADHESIVE,DENTURE,CARBOSYMETHYLCELLULOSE SODIUM(32%) AND ETHYLENE-OXIDE HOMOPOLY
• Product Code: KOL
• Date Received: 2020-02-13
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GLAXOSMITH KLINE CONSUMER HEALTH LP

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-13