FDA.reportPublic FDA data

MAUDE MDR 8448126

MDR report key
8448126
Report number
3012293198-2019-00038
Event key
0
Event type
3
Date received
2019-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Address
GLAXOSMITHKLINE RESEARCH TRIANGLE PARK PO BOX 13398 NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)ORAL SPRAYULTRADENT PRODUCTS INC/ORATECH LLCLFDR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2501. O

Event Narratives#

N

Patient 1

THIS REPORT # IS ASSOCIATED WITH ARGUS CASE (B)(4).

D

Patient 1

TIGHTNESS IN THROAT [THROAT TIGHTNESS], TINGLING IN THROAT [PHARYNGEAL PARESTHESIA], CHOKING FEELING [CHOKING SENSATION], HAVING SERIOUS ISSUES/SIDE EFFECT SLOWLY COME ON BY THE THIRD SPRAY [ADVERSE DRUG REACTION]. THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF THROAT TIGHTNESS IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY FOR PRODUCT USED FOR UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED SULFONAMIDE ALLERGY. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), THE PATIENT EXPERIENCED THROAT TIGHTNESS, TINGLING THROAT, CHOKING SENSATION AND DRUG SIDE EFFECT (SERIOUS CRITERIA OTHER: SERIOUS PER REPORTER). THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE THROAT TIGHTNESS, TINGLING THROAT, CHOKING SENSATION AND DRUG SIDE EFFECT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE THROAT TIGHTNESS, TINGLING THROAT, CHOKING SENSATION AND DRUG SIDE EFFECT TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ADDITIONAL DETAILS: THE CONSUMER ADVISED THAT ABSOLUTELY SHOULD NOT BE USED BY ANYONE WITH ALLERGY TO SULFA DRUGS AS SACCHARINE WAS A SULFONAMIDE DERIVATIVE. IT CAN BE DOWNRIGHT DEADLY DEPENDING ON HOW SENSITIVE OF A PERSON. CONSUMER EXPERIENCED TIGHTNESS AND TINGLING IN THROAT AND BUILDING CHOKING FEELING AND THE SIDE EFFECT SLOWLY CAME ON BY THE THIRD SPRAY OF THE DAY AND THE CONSUMER WAS STARTING TO HAVE SERIOUS ISSUES.