MAUDE MDR 384305

MDR report key
384305
Report number
MW4003229
Event key
0
Event type
3
Date received
2002-03-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ORA-FIXDENTURE ADHESIVEHOGIL PHARMACEUTICAL CORPKOQ***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12002-03-190

Event Narratives#

D

Patient 1

CONSUMER OPENED NEW CONTAINER OF ORA-FIX TO USE IT. CONSUMER HAD USED THIS PRODUCT FOR YEARS AND KNEW THAT IT SHOULD LOOK PINKISH AND CREAMY, THIS PARTICULAR TUBE WAS RED AND SANDY. CONSUMER PUT IT ON THE DENTURES AND WITHIN A FEW MINS CONSUMER BEGAN TO FEEL BURNING OF EYES AND THROAT, AND FEELING PECULIAR, THE PRODUCT GAVE CONSUMER A SEVERE SORE THROAT. CONSUMER TRIED TO WASH IT OFF IT TOOK CONSUMER 15 MINS TO DO SO, AND CONSUMER NOTED THAT THE ORA-FIX HAD EATEN AWAY AT THE DENTURES AND IT WAS STUCK TO THE ROOF OF MOUTH. NOW CONSUMER NOTED THAT THE STUFF IS EATING AWAY AT THE ACTUAL CONTAINER. CONSUMER RETURNED THE PRODUCT TO STORE WHERE CONSUMER HAD PURCHASED IT. THEN CALLED THE MFR CONSUMER LINE. SPOKE TO REP AND WAS TOLD TO RETURN THE TUBE AND THEIR INSURANCE DEPT WOULD GET IN TOUCH WITH CONSUMER. CONSUMER WENT TO STORE AND RETRIEVED THE TUBE OF ORA-FIX AND HAS IT AT HOME. CONSUMER ALSO HAS PURCHASED A NEW TUBE WITH DIFFERENT LOT NUMBER (# 80615" WICH IS USING NOW WITH OLD DENTURE, BECAUSE THE NEW ONES CONSUMER HAVE BEEN DAMAGED BY THE TUBE OF ORA-FIX IN QUESTION. CONSUMER RECEIVED SEVERE BURNING OF MOUTH WATERY EYES, AND SORE THROAT.