FDA.reportPublic FDA data

MAUDE MDR 8103192

MDR report key
8103192
Report number
3012293198-2018-00014
Event key
0
Event type
3
Date received
2018-11-26
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 MOUTH SPRAY (ORIGINAL)ORAL SPRAYULTRADENT PRODUCTS INC/ORATECH LLCLFDU6J221R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-2601. O

Event Narratives#

N

Patient 1

MFR REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE MOUTH SPRAY (ORIGINAL).

D

Patient 1

WENT DIRECTLY ON HIS THROAT AND ITS CHOKING HIM [CHOKING], I AM CALLING TO REPORT THAT MY HUSBAND ACCIDENTALLY SWALLOWED THE BIOTENE SPRAY LIQUID [ACCIDENTAL DEVICE INGESTION], EXPIRATION DATE IS 31 "JULLY" 2018 [EXPIRED DEVICE USED]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF CHOKING IN A MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (ORIGINAL)) OROMUCOSAL SPRAY (BATCH NUMBER U6J221, EXPIRY DATE 31ST JULY 2018) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED CHOKING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND EXPIRED DEVICE USED. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE CHOKING, ACCIDENTAL DEVICE INGESTION AND EXPIRED DEVICE USED WERE UNKNOWN. THE REPORTER CONSIDERED THE CHOKING AND ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE EXPIRED DEVICE USED TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 20 NOVEMBER 2018. CONSUMER STATED, "I AM CALLING TO REPORT THAT MY HUSBAND ACCIDENTALLY SWALLOWED THE BIOTENE SPRAY, WHEN HE SPRAYED IT, IT WENT DIRECTLY ON HIS THROAT AND 'ITS' CHOKING HIM REALLY BAD. I WANT TO KNOW WHAT IN THE PRODUCT "THAT" MIGHT BE BAD FOR HIM".