EFFERGRIP DENTURE ADHESIVE CREAM
Received Feb 6, 2006 · Event occurred Jan 1, 2004
Report 2246407-2006-00001 · MDR key 672752
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
73 YR
- Other (for use when an appropriate patient code cannot be identified)
- Sleep Dysfunction
Narrative
Description of Event or Problem
A PATIENT BEGAN USING EFFERGRIP DENTURE ADHESIVE CREAM (CARBOXYMETHYLCELLULOSE SODIUM, MALEIC ANHYDRIDE, METHYL VINYL ETHER) 4-5 TIMES DAILY TO HOLD HIS DENTURES APPROXIMATELY IN 2004. THE CONSUMER REPORTED THAT HE HAS BEEN USING THE PRODUCT 4-5 TIMES DAILY SINCE THE PRODUCT ONLY HOLDS HIS DENTURES FOR ABOUT 2 HOURS. AS OF DEC 2005 HE WAS CONTINUING TO USE THE PRODUCT. ADDITIONAL INFORMATION RECEIVED BY PFIZER IN JAN 2006 UPGRADES THIS CASE TO SERIOUS: THE PATIENT REPORTED HE HAS BEEN USING THE PRODUCT FOR ONE AND A HALF YEARS, 6 TIMES A DAY AND HAS BEEN HAVING SLEEP APNEA AND CENTRAL NERVOUS SYSTEM DISORDER DESCRIBED AS FACIOSCAPULOHUMERAL. HE NO LONGER USES THE PRODUCT AND THE OUTCOME OF THE EVENTS IS UNKNWON.