MAUDE MDR 304268

MDR report key
304268
Report number
MW4002891
Event key
0
Event type
3
Date of event
2000-09-14
Date received
2000-09-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPER WERNETSDENTURE ADHESIVE POWDERBLOCK DRUG COKOPNANISA069 0970811014NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-09-1501. O

Event Narratives#

D

Patient 1

CONSUMER REPORTED BURNING SENSATION IN MOUTH AFTER USING PRODUCT. USES THIS PRODUCT ALL THE TIME. THIS WAS A NEW CONTAINER. VISITED PERSONAL PHYSICIAN AND LOCAL ER - NEITHER COULD SEE ANYTHING WRONG, AND ADVISED CONSUMER TO DRINK COOL DRINKS AND TO COME BACK IF THEY HAD DIFFICULTY BREATHING. NO TREATMENT BY EITHER FACILITY. CONSUMER SAID THEY GOT UP IN THE MORNING, TOOK MEDICATIONS WITH WATER AS THEY USUALLY DO, AND THEN USED THE DENTURE POWDER. AS SOON AS CONSUMER TASTED THE DENTURE POWDER, THEY NOTICED IT HAD A "HORRIBLE" TASTE. CONSUMER COULD NOT DESCRIBE THE TASTE ANY FURTHER OTHER THAN THAT IT WAS "LIKE A CHEMICAL TASTE". CONSUMER SAID THE USUAL TASTE IS A "MEDICINEY/MINTY" TASTE. DR COULD NOT SEE ANYTHING IN THROAT AND SAID THAT THE IRRITATION WAS "TOO FAR DOWN" FOR DR TO SEE ANYTHING, AND DR DIDN'T WANT TO INJURE CONSUMER'S THROAT ANY FURTHER. CONSUMER SAID THEIR THROAT IS STILL SORE AND RAW TODAY. THERE IS NOTHING DIFFERENT IN THE LABELING OF THIS PRODUCT - NO NEW INGREDIENTS, ETC. CONSUMER HAD NOT EATEN OR DRUNK ANYTHING PRIOR TO USING THE PRODUCT. CALLED POISON CONTROL WHO TOLD CONSUMER THERE WAS NOTHING TOXIC IN IT. PER DRUGSTORE NO OTHER COMPLAINTS HAVE BEEN RECEIVED, AND ADDED THAT IT IS ONE OF ITS BEST SELLERS. THE PRODUCT WAS MADE AT BLOCK DRUG CO. THIS PLANT CLOSED. THIS PRODUCT IS NOW BEING MADE IN IRELAND. MFR REPORTED THAT ALL COMPLAINTS RECEIVED FOR THE PAST YEAR AND FOUND NO COMPLAINTS OF BURNING OR OFF TASTE.