FDA.reportPublic FDA data

MAUDE MDR 8148786

MDR report key
8148786
Report number
9615332-2018-00172
Event key
0
Event type
3
Date received
2018-12-10
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 ORAL RINSE (UNSPECIFIED VARIANT)ORAL RINSESKIK CUSTOM PRODUCTSLFDUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-1001. H; 2. O

Event Narratives#

N

Patient 1

9615332-2018-00172 IS ASSOCIATED WITH ARGUS CASE (B)(4), BIOTENE ORAL RINSE (UNSPECIFIED VARIANT).

D

Patient 1

I ENDED UP IN THE HOSPITAL WITH A SEVERE POTASSIUM DEFICIENCY [POTASSIUM DEFICIENCY]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF POTASSIUM DEFICIENCY IN A PATIENT WHO RECEIVED GLYCERIN (BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)) MOUTH WASH (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE ORAL RINSE (UNSPECIFIED VARIANT). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE ORAL RINSE (UNSPECIFIED VARIANT), THE PATIENT EXPERIENCED POTASSIUM DEFICIENCY (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT). BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) WAS DISCONTINUED (DECHALLENGE WAS UNKNOWN). ON AN UNKNOWN DATE, THE OUTCOME OF THE POTASSIUM DEFICIENCY WAS UNKNOWN. THE REPORTER CONSIDERED THE POTASSIUM DEFICIENCY TO BE RELATED TO BIOTENE ORAL RINSE (UNSPECIFIED VARIANT). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS, ADVERSE EVENT INFORMATION WAS RECEIVED ON (B)(6) 2018 VIA FACEBOOK. CONSUME POSTED THAT "I USED THIS FOR OVER 3 WEEKS WHEN MY MOUTH WAS SO DRY. IT WORKED TEMPORARILY, BUT I ENDED UP IN THE HOSPITAL WITH A SEVERE POTASSIUM DEFICIENCY. PLEASE EVERYONE TRY TO FIND THE CAUSE OF YOUR DRY MOUTH BEFORE MASKING IT".