SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)

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 2020-02-28 for SUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA) manufactured by Glaxosmithkline Dungarvan Ltd.

MAUDE Entry Details

Report Number3003721894-2020-00033
MDR Report Key9769440
Report SourceCONSUMER
Date Received2020-02-28
Date of Report2020-01-15
Date of Event2020-01-10
Date Mfgr Received2020-02-25
Date Added to Maude2020-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetPO BOX 13398 RESEARCH TRIANGLE PARK,
Manufacturer CityNC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPER POLIGRIP EXTRA CARE (ZINC FREE FORMULA)
Generic NameDENTURE ADHESIVE
Product CodeKOT
Date Received2020-02-28
Lot NumberP59Y
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD
Manufacturer AddressDUNGARVAN, WATERFORD, EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-28

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