FDA Adverse Event Summary report: N

BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)

MDR report key: 4615659 · Received March 18, 2015

Report

Report Number
1718912-2015-00008
Date Received
March 18, 2015
Report Date
March 13, 2015
Manufacturer
ULTRADENT PRODUCTS INC/ORA TECH LLC
Product Code
NTO
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
185101 BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) ORAL SPRAY NTO ULTRADENT PRODUCTS INC/ORA TECH LLC

Patients

Seq Age Sex Outcome Treatment
1 Other