MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-13 for BIOTENE MOISTURIZING MOUTH SPRAY manufactured by Ultradent Products Inc/oratech Llc.
[174667275]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174667276]
Patient passed away [unknown cause of death]. Patient was having a hard time swallowing [swallowing difficult]. Patient felt discomfort [discomfort]. Case description: this case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a (b)(6) female patient who received glycerin (biotene moisturizing mouth spray) oromucosal spray for dry mouth. On (b)(6) 2019, the patient started biotene moisturizing mouth spray 44 ml. On (b)(6) 2019, an unknown time after starting biotene moisturizing mouth spray, the patient experienced unknown cause of death (serious criteria death and gsk medically significant), swallowing difficult, discomfort and wrong technique in product usage process. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the swallowing difficult, discomfort and wrong technique in product usage process were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, swallowing difficult and discomfort to be related to biotene moisturizing mouth spray. Additional details: consumer reported because of biotene. His wife passed away last friday. She was terminally ill. The nurse suggested she gave her biotene because of her dry mouth. Consumer tried to give her some last wednesday, consumer could only do it when her mouth was open. It did not come out as a spray, it was a gel. She closed her mouth right after consumer gave it to her, and obviously felt discomfort with it. She had a hard time swallowing the next morning, consumer had to wipe her lips, the stuff was caked all around her mouth. Consumer was saying that they should inform that it was not a product that should be used in a case like this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012293198-2019-00185 |
| MDR Report Key | 9580317 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK, |
| Manufacturer City | NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE MOISTURIZING MOUTH SPRAY |
| Generic Name | ORAL SPRAY |
| Product Code | LFD |
| Date Received | 2020-01-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC/ORATECH LLC |
| Manufacturer Address | SOUTH JORDAN UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2020-01-13 |