MAUDE Adverse Event Report: ULTRADENT PRODUCTS INC/ORA TECH LLC BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION); ORAL SPRAY

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)
• Type of Device: ORAL SPRAY
• Manufacturer (Section D): ULTRADENT PRODUCTS INC/ORA TECH LLC; south jordan UT
• Manufacturer (Section G): GSK
• Manufacturer Contact: p.o box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 4615659
• MDR Text Key: 5592399
• Report Number: 1718912-2015-00008
• Device Sequence Number: 1
• Product Code: NTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other