FDA.reportPublic FDA data

MAUDE MDR 8208806

MDR report key
8208806
Report number
3012293198-2018-00015
Event key
0
Event type
3
Date received
2019-01-02
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
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 LLCLFDU8H101R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-0201. H; 2. O

Event Narratives#

N

Patient 1

REPORT # 3012293198-2018-00015 IS ASSOCIATED WITH (B)(4), BIOTENE MOUTH SPRAY.

D

Patient 1

IT CAUSED ME HOSPITALIZATION [HOSPITALIZATION]; MY THROAT WAS ON FIRE AND CLOSED DOWN [BURNING IN THROAT]; MY THROAT WAS ON FIRE AND CLOSED DOWN. [THROAT CONSTRICTION]; I JUST HAD AN IMMEDIATE VIOLENT REACTION WITH IT. [ADVERSE DRUG REACTION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF HOSPITALIZATION IN A (B)(6) YEAR-OLD MALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (ORIGINAL)) OROMUCOSAL SPRAY (BATCH NUMBER USH101, EXPIRY DATE 31ST JULY 2020) FOR DRY MOUTH. ON (B)(6) 2018, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED HOSPITALIZATION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BURNING IN THROAT, THROAT CONSTRICTION AND ADVERSE DRUG REACTION. THE PATIENT WAS TREATED WITH OXYBUTYNIN. BIOTENE MOUTH SPRAY (ORIGINAL) WAS DISCONTINUED ON (B)(6) 2018 (DECHALLENGE WAS POSITIVE). ON AN UNKNOWN DATE, THE OUTCOME OF THE HOSPITALIZATION, BURNING IN THROAT, THROAT CONSTRICTION AND ADVERSE DRUG REACTION WERE RECOVERING/RESOLVING. THE REPORTER CONSIDERED THE HOSPITALIZATION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BURNING IN THROAT, THROAT CONSTRICTION AND ADVERSE DRUG REACTION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). ADDITIONAL INFORMATION: ADVERSE EVENT INFORMATION WAS RECEIVED ON 18 DECEMBER 2018. CONSUMER REPORTED THAT, "I HAVE USED YOUR PRODUCT BEFORE AND RECENTLY I GOT BIOTENE SPRAY THE MINT FLAVOR 1.5OZ, IT CAUSED ME HOSPITALIZATION. MY THROAT WAS ON FIRE AND CLOSED DOWN. I WAS GIVEN OXYBUTYNIN. I HAVE USED THE SPRAY 2 DAYS AGO BUT ONLY USED IT FOR ONE DAY. MY CONDITION HAS IMPROVED AND YES COULD CALL THE PHYSICIAN THAT CHECKED ME. I GOT THE SPRAY, IT HAS A LOT ID USH101 AND EXPIRY DATE JULY 2020. I JUST HAD AN IMMEDIATE VIOLENT REACTION WITH IT."