MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-12-17 for BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION manufactured by Kik Custom Products.
[130538129]
Mfr report # 9615332-2018-00183 is associated with argus (b)(4), biotene dry mouth gentle oral rinse mild mint solution.
Patient Sequence No: 1, Text Type: N, H10
[130538130]
I was just wondering why the label says not to drink from the bottle when you're rinsing. I've been doing that [intentional device misuse]. Case description: this case was reported by a consumer and described the occurrence of intentional device misuse in a female patient who received glycerin (biotene dry mouth gentle oral rinse mild mint solution) mouth wash for product used for unknown indication. On an unknown date, the patient started biotene dry mouth gentle oral rinse mild mint solution. On an unknown date, an unknown time after starting biotene dry mouth gentle oral rinse mild mint solution, the patient experienced intentional device misuse (serious criteria gsk medically significant). The action taken with biotene dry mouth gentle oral rinse mild mint solution was unknown. On an unknown date, the outcome of the intentional device misuse was unknown. It was unknown if the reporter considered the intentional device misuse to be related to biotene dry mouth gentle oral rinse mild mint solution. Additional information: adverse event information was received via call on (b)(6) 2018. The consumer reported about biotene gentle oral rinse that, "i was just wondering why the label says not to drink from the bottle when you're rinsing. I've been doing that. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615332-2018-00183 |
| MDR Report Key | 8170011 |
| Report Source | CONSUMER |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-10 |
| Date Mfgr Received | 2018-12-10 |
| Date Added to Maude | 2018-12-17 |
| 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 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTION |
| Generic Name | ORAL RINSES |
| Product Code | LFD |
| Date Received | 2018-12-17 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIK CUSTOM PRODUCTS |
| Manufacturer Address | ETOBICOKE, ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |