MAUDE MDR 4615659

MDR report key
4615659
Report number
1718912-2015-00008
Event key
0
Event type
3
Date received
2015-03-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Address
P.O 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 SPRAY (2013 FORMULATION)ORAL SPRAYULTRADENT PRODUCTS INC/ORA TECH LLCNTOR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-03-1801. O

Event Narratives#

D

Patient 1

PARKISON'S DISEASE AGGRAVATED (PARKINSON'S DISEASE AGGRAVATED) SHAKING (TREMOR). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF PARKINSON'S DISEASE AGGRAVATED IN A FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) OROMUCOSAL SPRAY (BATCH NUMBER UNK, EXPIRY DATE UNK) FOR AN UNKNOWN INDICATION. CONCURRENT MEDICAL CONDITIONS INCLUDED PARKINSON'S DISEASE. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) (DENTAL) AT AN UNKNOWN DOSE AND FREQUENCY. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION), THE PATIENT EXPERIENCED PARKINSON'S DISEASE AGGRAVATED (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT) AND TREMOR. THE ACTION TAKEN WITH BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE PARKINSON'S DISEASE AGGRAVATED AND TREMOR WERE UNKNOWN. THE REPORTER CONSIDERED THE PARKINSON'S DISEASE AGGRAVATED AND TREMOR TO BE RELATED TO BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION). ADDITIONAL DETAILS: CONSUMER REPORTED USING BIOTENE MOUTH SPRAY, AND IT MADE HER PARKINSON'S DISEASE WORSE.