POLIDENT ADHESIVE FRESHMINT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-06-22 for POLIDENT ADHESIVE FRESHMINT manufactured by Glaxosmithkine Dungarvan Ltd.

Event Text Entries

[5866016] Anaphylactic reaction (anaphylactic reaction). Unable to eat. Not able to swallow. Unable to talk. Throat swollen. Case description: this case was reported by a consumer and described the occurrence of anaphylactic reaction in a (b)(6) female patient who received double salt dental adhesive cream (polident adhesive freshmint) cream for product used for unknown indication. Concurrent medical conditions included drug allergy (morphine), penicillin allergy, drug allergy (codeine), drug allergy (aspirin), drug allergy (nsaids), latex allergy, rubber sensitivity, drug allergy (champix), meat allergy (pork) and peanut allergy. Additional patient notes included allergy to natural anti-inflammatories and allergy to anchovies. On an unknown date, the patient started polident adhesive freshmint. On (b)(6) 2012, an unknown time after starting polident adhesive freshmint, the patient experienced anaphylactic reaction (serious criteria gsk medically significant). On an unknown date, the patient experienced not able to swallow, unable to eat (serious criteria gsk medically significant), unable to talk and throat swollen. On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved and the outcome of the not able to swallow, unable to eat, unable to talk and throat swollen were unknown. The reporter considered the anaphylactic reaction to be possibly related to polident adhesive freshmint. It was unknown if the reporter considered the not able swallow, unable to eat, unable to talk and throat swollen to be related to polident adhesive freshmint. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: ae verbatim: i'm not sure if the reaction was from the adhesive or the dentures themselves. 2 years ago i ended up in casualty as i was not able to swallow, eat or talk and my throat was swollen like a cane toad (means it is very swollen). The hospital put me on an iv with anti-biotics, i think before i was allowed to go home. At this time i went to my dentist who removed my denture (the dentist used polident fresh adhesive cream to keep my denture in place). 2 hours later the swelling disappeared. Since then i have no teeth in my mouth. I've been told i'm allergic to acrylate material so i was wondering if the adhesive had any in it. I have been told that my denture did. Please note this event happened the day she had her new dentures fitted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2014-00052
MDR Report Key4865012
Report Source01,04
Date Received2015-06-22
Date of Report2014-11-20
Date of Event2012-11-20
Date Mfgr Received2014-11-20
Date Added to Maude2015-07-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer StreetP.O BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Manufacturer G1GSK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePOLIDENT ADHESIVE FRESHMINT
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-06-22
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKINE DUNGARVAN LTD
Manufacturer AddressDUNGARVAN EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-22

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