MAUDE MDR 477703

MDR report key
477703
Report number
9681138-2003-00003
Event key
0
Event type
3
Date of event
2003-06-01
Date received
2003-08-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1500 LITTLETON RD PARSIPPANY NJ 07054 US
Phone
973-973-9738
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUPER POLIGRIP FREE DENTURE ADHESIVE CREAMDENTURE ADHESIVEGLAXOSMITHKLINEKOP**R03102NNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-08-0821. O

Event Narratives#

D

Patient 1

THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ALLERGIC REACTION IN A CONSUMER WHO USED SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM (TRIPLE GANTREZ SALT AND SODIUM CARBOXYMETHYLCELLULOSE.). A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDE ALLERGY TO BEES, ALLERGY TO SUPER POLIGRIP, (UNSPECIFIED FORMULATION, DATE AND REACTION), AND ALLERGY TO FIXODENT. THE CONSUMER CARRIES AN EPI-PEN FOR THEIR BEE ALLERGY. CONCURRENT MEDICATIONS INCLUDE DIAZEPAM, LORCET, RANITIDINE HYDROCHLORIDE (ZANTAC) AND PREMPRO. A FEW YEARS AGO, THE CONSUMER STARTED USING SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM (DOUBLE GANTREZ SALT AND SODIUM CARBOXYMETHYLCELLULOSE) UNEVENTFULLY. IN 2003 THE CONSUMER BEGAN USING THE SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM, (TRIPLE GANTREZ SALT AND SODIUM CORBOXYMETHYLCELLULOSE). AFTER THEIR FIRST APPLICATION OF THE TRIPLE SALT FORMULATION THE CONSUMER EXPERIENCED AN ALLERGIC REACTION DESCRIBED AS THROAT SWELLING AND DIFFICULTY BREATHING. THE CONSUMER TOOK DIPHENHYDRAMINE HYDROCHLORIDE AND REMOVED THEIR DENTURES AT HOME BUT DID NOT USE THEIR EPI-PEN. THE CONSUMER STATED THEY KNEW IT WAS AN ALLERGIC REACTION BECAUSE THEY EXPERIENCED A SIMILAR REACTION TO FIXODENT IN THE PAST. IT IS UNK WHAT TYPE OF REACTION THE CONSUMER HAD TO SUPER POLIGRIP IN THE PAST. PT DROVE THEMSELVES TO THE EMERGENCY ROOM. IN THE EMERGENCY RROM THEY RECEIVED A SHOT WHICH THEY BELIEVED WAS ADRENALINE. THE EVENTS RESOLVED QUICKLY AND CONSUMER WAS RELEASED FROM THE EMERGENCY ROOM 20 MINUTES LATER. THE CONSUMER HAS NOT RESTARTED THE SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM (TRIPLE GANTREZ SALT AND SODIUM CARBOXYMETHYLCELLULOSE. MANUFACTURER'S COMMENT: THIS CASE HAD BEEN ASSESSED AS MEDICALLY SERIOUS BY THE SAFETY PHYSICIAN.