FDA.reportPublic FDA data

MAUDE MDR 8469241

MDR report key
8469241
Report number
3012293198-2019-00039
Event key
0
Event type
3
Date received
2019-04-01
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
PO BOX 13398 RESEARCH TRIANGLE PARK 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 LLCLFDU8G131R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0101. O

Event Narratives#

N

Patient 1

MFR REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4).

D

Patient 1

TIGHTNESS IN THE PATIENT?S THROAT [THROAT TIGHTNESS], TINGLING IN THE PATIENT?S THROAT [PHARYNGEAL PARESTHESIA], BUILDING CHOKING FEELING [CHOKING SENSATION], ANAPHYLACTIC SHOCK [ANAPHYLACTIC SHOCK]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF THROAT TIGHTNESS IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)) OROMUCOSAL SPRAY FOR DRUG USE 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 AND CHOKING SENSATION. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE THROAT TIGHTNESS, TINGLING THROAT AND CHOKING SENSATION WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE THROAT TIGHTNESS, TINGLING THROAT AND CHOKING SENSATION TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ADDITIONAL DETAILS: THE REPORTER SAID IT SHOULD NOT BE USED BY ANYONE WITH ALLERGY TO SULFA DRUGS. IT COULD DOWNRIGHT DEADLY DEPENDING UPON SENSITIVITY OF PATIENT. THE PATIENT REPORTED TIGHTNESS AND TINGLING IN THROAT, A BUILDING CHOKING SENSATION. THE SIDE EFFECT CAME ON THIRD SPRAY OF DAY AND STARTED TO HAVE SERIOUS ISSUE. FOLLOW UP INFORMATION WAS RECEIVED ON 07 MAR 2019: LOT CODE WAS (BATCH NUMBER U8G131). THE PATIENT EXPERIENCED ANAPHYLACTIC SHOCK (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ANAPHYLACTIC SHOCK WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ANAPHYLACTIC SHOCK TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). REASON FOR USE DRY MOUTH STARTED. THE PATIENT SWA HEALTH CARE PROFESSIONAL REGARDING EXPERIENCE. THE PATIENT WAS TAKEN TO EMERGENCY ROOM FOR ANAPHYLACTIC SHOCK.