NEW POLIGRIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-11-11 for NEW POLIGRIP manufactured by Glaxosmithkline Dungarvan Ltd.

MAUDE Entry Details

Report Number3003721894-2019-00172
MDR Report Key9304060
Report SourceFOREIGN
Date Received2019-11-11
Date of Report2019-06-25
Date Mfgr Received2019-06-25
Date Added to Maude2019-11-11
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 StreetPO BOX 13398
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEW POLIGRIP
Generic NameDENTURE ADHESIVE
Product CodeKOT
Date Received2019-11-11
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGLAXOSMITHKLINE DUNGARVAN LTD
Manufacturer AddressDUNGARVAN, WATERFORD EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-11

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