FDA.reportPublic FDA data

MAUDE MDR 9580317

MDR report key
9580317
Report number
3012293198-2019-00185
Event key
0
Event type
3
Date received
2020-01-13
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 MOISTURIZING MOUTH SPRAYORAL SPRAYULTRADENT PRODUCTS INC/ORATECH LLCLFDR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1301. D; 2. O

Event Narratives#

N

Patient 1

ARGUS CASE (B)(4).

D

Patient 1

PATIENT PASSED AWAY [UNKNOWN CAUSE OF DEATH]. PATIENT WAS HAVING A HARD TIME SWALLOWING [SWALLOWING DIFFICULT]. PATIENT FELT DISCOMFORT [DISCOMFORT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF UNKNOWN CAUSE OF DEATH IN A (B)(6) FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY) OROMUCOSAL SPRAY FOR DRY MOUTH. ON (B)(6) 2019, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY 44 ML. ON (B)(6) 2019, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY, THE PATIENT EXPERIENCED UNKNOWN CAUSE OF DEATH (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT), SWALLOWING DIFFICULT, DISCOMFORT AND WRONG TECHNIQUE IN PRODUCT USAGE PROCESS. ON AN UNKNOWN DATE, THE OUTCOME OF THE UNKNOWN CAUSE OF DEATH WAS FATAL AND THE OUTCOME OF THE SWALLOWING DIFFICULT, DISCOMFORT AND WRONG TECHNIQUE IN PRODUCT USAGE PROCESS WERE UNKNOWN. THE REPORTED CAUSE OF DEATH WAS UNKNOWN CAUSE OF DEATH. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE UNKNOWN CAUSE OF DEATH, SWALLOWING DIFFICULT AND DISCOMFORT TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY. ADDITIONAL DETAILS: CONSUMER REPORTED BECAUSE OF BIOTENE. HIS WIFE PASSED AWAY LAST FRIDAY. SHE WAS TERMINALLY ILL. THE NURSE SUGGESTED SHE GAVE HER BIOTENE BECAUSE OF HER DRY MOUTH. CONSUMER TRIED TO GIVE HER SOME LAST WEDNESDAY, CONSUMER COULD ONLY DO IT WHEN HER MOUTH WAS OPEN. IT DID NOT COME OUT AS A SPRAY, IT WAS A GEL. SHE CLOSED HER MOUTH RIGHT AFTER CONSUMER GAVE IT TO HER, AND OBVIOUSLY FELT DISCOMFORT WITH IT. SHE HAD A HARD TIME SWALLOWING THE NEXT MORNING, CONSUMER HAD TO WIPE HER LIPS, THE STUFF WAS CAKED ALL AROUND HER MOUTH. CONSUMER WAS SAYING THAT THEY SHOULD INFORM THAT IT WAS NOT A PRODUCT THAT SHOULD BE USED IN A CASE LIKE THIS.