InjuryEBO

QUIK-FIX

Received Aug 17, 2000 · Event occurred Jan 1, 2000

Report MW1019683 · MDR key 291173

Device

Generic name

Denture Repair Kit

Manufacturer

Brimms Laboratory Div Of Brimms, Inc.

Model number

Catalog number

BP9881

Lot number

129105

Product problems

Labelling, Instructions for Use or Training Problem
Device Emits Odor
Other (for use when an appropriate device code cannot be identified)

Patient

64 YR

Increased Sensitivity
Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

THE CONTAINER HAS NO LABELING AS TO ITS INGREDIENTS AND IT HAS A VERY POTENT ODOR WHICH INCAPACITATED THE USER. THE USER APPLIED IT WITH A FAN IN USE. EVEN AFTER THE GLUE HAD DRIED AND THEY PLACED THEIR DENTURES IN THEIR MOUTH THE SMELL OF CHEMICALS FROM THE DENTURES WAS VERY POTENT. THE USER BELIEVES THAT WARNING AND CONTENT LABELS ARE INADEQUATE ESPECIALLY CONSIDERING THE RISK OF ALLERGIES TO THE PT. RPTR IS STILL QUITE SENSITIVE TO CHEMICAL ODORS AT THIS TIME.