POLIGRIP EXTRA STRENGTH POWDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-16 for POLIGRIP EXTRA STRENGTH POWDER manufactured by Glaxo-smith.

Event Text Entries

[36708146] Was diagnosed with early stage bladder cancer (b)(6) 2015. Trying to figure out why, i suspect it might be associated with the use of polident's poligrip denture adhesive powder. I began using the denture powder on a daily basis 23 months before. That was the only new ingredient ingested. All else continued as before. What adds to my suspicion was that during the time of my use the company halted production on grounds it could not obtain a needed ingredient. Consequently it became very difficult to find on store shelves and i prided myself, by chance having stocked up with several bottles beforehand, that i had an ample supply to last until supplies were once more available. As it turned out supplies did not start reappearing on shelves until at least over a year later. It could have been more, but by then i was no longer keeping track. I still have at home some of the original powder that i can give you to test for possible carcinogens. Fyi i never smoked and have been a vegetarian since the mid-eighties so my bladder cancer cannot be attributed to risks associated with their opposites. Date of use: 23 months. Diagnosis or reason for use: hold upper partial denture in place. Still have lower teeth. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059515
MDR Report Key5383925
Date Received2016-01-16
Date of Report2016-01-16
Date of Event2015-06-23
Date Added to Maude2016-01-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePOLIGRIP EXTRA STRENGTH POWDER
Generic NamePOLIGRIP DENTURE ADHESIVE
Product CodeKOL
Date Received2016-01-16
Lot NumberN13224
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGLAXO-SMITH


Patients

Patient NumberTreatmentOutcomeDate
10 2016-01-16

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