FDA.reportPublic FDA data

MAUDE MDR 8279246

MDR report key
8279246
Report number
3012293198-2019-00005
Event key
0
Event type
3
Date received
2019-01-25
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
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOTENEUNKNOWNULTRADENT PRODUCTS INC/ORATECH LLCLFDR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-2501. O

Event Narratives#

N

Patient 1

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

D

Patient 1

SJ?GREN'S SYNDROME [SJOGREN'S SYNDROME]. BLISTER [BLISTER]. BURN MOUTH [BURNING MOUTH]. DRY MOUTH [DRY MOUTH]. LACK OF EFFICACY [DEVICE INEFFECTIVE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF SJOGREN'S SYNDROME IN A FEMALE PATIENT WHO RECEIVED BIOTENE ORAL BALANCE UNKNOWN FORMULATION (BIOTENE) UNKNOWN FOR DRUG USE FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE, THE PATIENT EXPERIENCED SJOGREN'S SYNDROME (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BLISTER, BURNING MOUTH (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), DRY MOUTH AND DEVICE INEFFECTIVE. THE ACTION TAKEN WITH BIOTENE WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE SJOGREN'S SYNDROME, BLISTER, BURNING MOUTH AND DRY MOUTH WERE NOT REPORTED AND THE OUTCOME OF THE DEVICE INEFFECTIVE WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE SJOGREN'S SYNDROME, BLISTER, BURNING MOUTH, DRY MOUTH AND DEVICE INEFFECTIVE TO BE RELATED TO BIOTENE. THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL DETAILS: THE PATIENT GOT SJ?GREN'S SYNDROME WITH BLISTER, BURN MOUTH, DRY MOUTH. PATIENT REPORTED THAT PRODUCT DID NOT WORK.