SUPER POLIGRIP DENTURE ADHESIVE CREAM-UNIDENTIFIED *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-02-10 for SUPER POLIGRIP DENTURE ADHESIVE CREAM-UNIDENTIFIED * manufactured by Glaxosmithkline.

Event Text Entries

[308321] A consumer, who was hospitalized for an unspecified reason, experienced respiratory arrest in 2002, because their dentures slipped off from their gums, became lodged in their throat and blocked their airway. The nurse reported that the consumer had to be "intubated" until the attending physician pried their mouth open to remove the denture from their throat because the super poligrip that was used to keep the dentures in place had "sealed their gums together". The nurse stated that the consumer recovered soon after the consumer's dentures were removed from their throat. The nurse refused to provide additional info. Mfr comment: super poli-grip denture adhesive cream, mfg by block drug company, now glaxosmithkline, has been indentified as the suspect product in this case. The exact identity of the product is unknown, but it is believed to have been mfg in ireland. No correctiue actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681138-2003-00002
MDR Report Key442182
Report Source05
Date Received2003-02-10
Date of Report2003-02-06
Date of Event2002-11-01
Date Mfgr Received2003-01-08
Date Added to Maude2003-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPER POLIGRIP DENTURE ADHESIVE CREAM-UNIDENTIFIED
Generic NameDENTURE ADHESIVE
Product CodeKOP
Date Received2003-02-10
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 Key431160
ManufacturerGLAXOSMITHKLINE
Manufacturer Address1500 LITTLETON ROAD PARSIPPANY NJ 070543884 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-02-10

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