SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-10-26 for SUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT) manufactured by Glaxosmithkline Dungarvan Ltd..

Event Text Entries

[29972568] Death [unknown cause of death] and burning sensation on gums. This case was reported by a consumer and described the occurrence of unknown cause of death in a (b)(6) female patient who received double salt dental adhesive cream; super poligrip (unspecified zinc free variant) cream, batch number unk, expiration date unknown for product used for unknown indication. On an unknown date, the patient started super poligrip (unspecified zinc free variant). On an unknown date, an unknown time after starting super poligrip (unspecified zinc free variant), the patient experienced unknown cause of death (serious criteria death and gsk medically significant) and burning gum. Super poligrip (unspecified zinc free variant) was discontinued (dechallenge was positive). In 1995, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the burning gum was recovered and resolved. The patient died in 1995. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and burning gum to be related to super poligrip (unspecified zinc free variant). This report is made by gsk w/out prejudice and does not imply any admission or liability for the incident or its' consequences. Additional information: adverse event information was reported on october 16, 2015. The daughter reported that her now deceased mother used super poligrip denture adhesive cream (variant not specified) and experienced a burning sensation on her gums. The daughter reported that her mother was (b)(6) and died in 1995.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003721894-2015-00014
MDR Report Key5189102
Report SourceCONSUMER
Date Received2015-10-26
Date of Report2015-10-16
Date Mfgr Received2015-10-16
Date Added to Maude2015-10-29
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 FDA3
Event Location3
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 Report0

Device Details

Brand NameSUPER POLIGRIP (UNSPECIFIED ZINC FREE VARIANT)
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2015-10-26
Lot NumberUNK
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD.
Manufacturer AddressDUNGARVAN, WATERFORD EI


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Other 2015-10-26

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