SUPER POLYGRIP
Received Apr 19, 2001
Report MW4002987 · MDR key 328554
Device
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
NO INFO
Narrative
Description of Event or Problem
THE COMPLAINANT WANTED TO KNOW THE INGREDIENTS IN SUPER POLYGRIP BECAUSE THEY SOMETIMES SWALLOW THIS DENTURE ADHESIVE. SINCE THE PRODUCT IS CONSIDERED TO BE A DEVICE, THEY FOUND NO INGREDIENT STATEMENT ON THE LABEL. CALLED THE CO AND THEY REFUSED TO TELL COMPLAINANT THE INGREDIENTS. COMPLAINANT THINKS THAT THE FDA SHOULD SPONSOR LEGAL CHANGES TO REQUIRE THE LISTING OF INGREDIENTS ON ORAL DEVICES WHICH ARE NOT INTACT PIECES LIKE OTHER DEVICES.