FDA.reportPublic FDA data

MAUDE MDR 8560141

MDR report key
8560141
Report number
3012293198-2019-00056
Event key
0
Event type
3
Date received
2019-04-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
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 MOUTH SPRAY (UNKNOWN)ORAL SPRAYULTRADENT PRODUCTS INC/ORATECH LLCLFDUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-2901. O

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

I ACCIDENTALLY SPRAYED TOO FAR BACK IN MY THROAT [ACCIDENTAL DEVICE INGESTION]. I HAD A HARD TIME FALLING ASLEEP [SLEEPINESS]. I ACCIDENTALLY SPRAYED TOO FAR BACK IN MY THROAT, AND I IMMEDIATELY FELT A HORRIBLE BURNING SENSATION. [THROAT BURNING SENSATION OF]. I COUGHED SO HARD THAT I VOMITED. [COUGH]. I COUGHED SO HARD THAT I VOMITED. [VOMITING]. IT HURT WHEN I BREATHED [DIFFICULTY BREATHING]. IT HURT WHEN I BREATHED, AND I COULDN'T GET RID OF THE PAIN. [ORAL PAIN]. I LOOKED AT MY THROAT IN THE MIRROR AND IT WAS BRIGHT RED. [RED THROAT]. THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (UNKNOWN)) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (UNKNOWN) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (UNKNOWN), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), SLEEPINESS, THROAT BURNING SENSATION OF, COUGH, VOMITING, DIFFICULTY BREATHING, ORAL PAIN AND RED THROAT. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (UNKNOWN) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION WAS UNKNOWN AND THE OUTCOME OF THE SLEEPINESS, THROAT BURNING SENSATION OF, COUGH, VOMITING, DIFFICULTY BREATHING, ORAL PAIN AND RED THROAT WERE RECOVERING/ RESOLVING. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE MOUTH SPRAY (UNKNOWN). THE REPORTER CONSIDERED THE SLEEPINESS, THROAT BURNING SENSATION OF, COUGH, VOMITING, DIFFICULTY BREATHING, ORAL PAIN AND RED THROAT TO BE RELATED TO BIOTENE MOUTH SPRAY (UNKNOWN). ADDITIONAL INFORMATION, ADVERSE EVENT INFORMATION WAS RECEIVED ON 02 APRIL 2019 VIA INTERACTIVE DIGITAL MEDIA ((B)(6)). THE CONSUMER POSTED" HI. I ACCIDENTALLY SPRAYED MY THROAT AND IT FEELS LIKE IT WAS CHEMICALLY BURNED. HOW DO I MAKE IT GO AWAY?" FOLLOW-UP ADVERSE EVENT INFORMATION WAS RECEIVED ON 03 APRIL 2019 VIE EMAIL. THE CONSUMER STATED "HI I SENT A MESSAGE ON (B)(6) ABOUT WHAT HAPPENED WHEN USED THE BIOTENE SPRAY YESTERDAY. I ACCIDENTALLY SPRAYED TOO FAR BACK IN MY THROAT, AND I IMMEDIATELY FELT A HORRIBLE BURNING SENSATION. IT MADE ME COUGH, AND I COUGHED SO HARD THAT I VOMITED. IT HURT WHEN I BREATHED, AND I COULDN'T GET RID OF THE PAIN. I ENDED UP DRINKING A LOT OF ICE WATER AND SUCKED ON COUGH DROPS, BUT REALLY THE ONLY THING THAT MADE IT FEEL BETTER WAS WHEN I COUGHED. I MISSED OUT ON SOME ACTIVITIES IN THE AFTERNOON AND STARTED TO LOSE MY VOICE BECAUSE OF THE COUGHING. I LOOKED AT MY THROAT IN THE MIRROR AND IT WAS BRIGHT RED. I HAD A HARD TIME FALLING ASLEEP, BUT TODAY I FEEL A LOT BETTER. IT STILL HURTS, BUT NOT AS MUCH. I REALLY LIKE THIS PRODUCT BECAUSE I HAVE HORRIBLE DRY MOUTH AND NOTHING ELSE HAS HELPED, BUT I'M A LITTLE AFRAID TO USE IT AGAIN." INITIAL AND FOLLOW UP CASE WAS PROCESSED.