HYDENT ARTICULATION PASTE
Received Dec 7, 2011 · Event occurred Nov 16, 2011
Report 3011632-2011-00004 · MDR key 2466205
Device
Generic name
Denture Articulation Aerosol Paste
Manufacturer
Pascal Co., Inc.Model number
NACatalog number
05100
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
Patient
59 YR
- Diarrhea
- Vomiting
- Dizziness
- Loss of consciousness
- Sweating
Narrative
Description of Event or Problem
PATIENT REPORTED EXPERIENCING SYMPTOMS OF VOMITING, DIARRHEA, COLD SWEATS, DIZZINESS, AND LOSS OF CONSCIOUSNESS (LESS THAN 1 MINUTE) SEVERAL HOURS AFTER BEING ADMINISTERED HYDENT, AN AEROSOL DENTURE ARTICULATION PASTE. THE PATIENT REPORTED EXPERIENCING SYMPTOMS AFTER EACH ADMINISTRATION, WITH THE SECOND ADMINISTRATION PRODUCING MORE SEVERE SYMPTOMS THAN THE FIRST. THE PATIENT SOUGHT MEDICAL ATTENTION SEVERAL DAYS AFTER THE LAST APPEARANCE OF THE SYMPTOMS. PLEASE NOTE: THIS IS A RE-SUBMISSION OF THE ORIGINAL REPORT SENT (B)(4) 2011.
Additional Manufacturer Narrative
CONTENTS OF HYDENT: SOYBEAN OIL, ZINC OXIDE, MINT FLAVOR, AEROSOL PROPELLANT.