MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-03-18 for BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) manufactured by Ultradent Products Inc/ora Tech Llc.
[5592399]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2015-00008 |
| MDR Report Key | 4615659 |
| Report Source | 04 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-13 |
| Date Mfgr Received | 2015-03-13 |
| Date Added to Maude | 2015-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION) |
| Generic Name | ORAL SPRAY |
| Product Code | NTO |
| Date Received | 2015-03-18 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORA TECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-18 |