FDA.reportPublic FDA data

MAUDE MDR 672752

MDR report key
672752
Report number
2246407-2006-00001
Event key
0
Event type
3
Date of event
2004-01-01
Date received
2006-02-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
201 TABOR ROAD MORRIS PLAINS NJ 07950 US
Phone
973-973-9733
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EFFERGRIP DENTURE ADHESIVE CREAMDENTURE PRODUCTPFIZER INC.KOQUNKUNK102840NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-02-0601. O

Event Narratives#

D

Patient 1

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.