SUPER WERNETS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-15 for SUPER WERNETS manufactured by Block Drug Co.

Event Text Entries

[17173542] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002891
MDR Report Key304268
Date Received2000-09-15
Date of Report2000-09-15
Date of Event2000-09-14
Date Added to Maude2000-11-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSUPER WERNETS
Generic NameDENTURE ADHESIVE POWDER
Product CodeKOP
Date Received2000-09-15
Model NumberNA
Catalog NumberNI
Lot NumberSA069 0970811014
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key294453
ManufacturerBLOCK DRUG CO
Manufacturer Address* S BRUNSWICK NJ * US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-09-15

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