MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-13 for BIOTENE DRY MOUTH ORAL RINSE manufactured by Glaxosmithkline.
[47417773]
I used biotene dry mouth oral rinse for 4 days, i noticed on the 3rd day my teeth seemed sensitive to drinks. By the 4th day, it hurts to even touch my teeth. By the end of that day, part of my filling had fell out. It took almost a week for my teeth to feel normal again. Dose or amount: tablespoon. Frequency: twice a day. Route: taken by mouth. Dates of use: (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062841 |
| MDR Report Key | 5725460 |
| Date Received | 2016-06-13 |
| Date of Report | 2016-06-11 |
| Date of Event | 2016-06-01 |
| Date Added to Maude | 2016-06-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE DRY MOUTH ORAL RINSE |
| Generic Name | BIOTENE DRY MOUTH ORAL RINSE |
| Product Code | NTO |
| Date Received | 2016-06-13 |
| Lot Number | 6D14C2A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-13 |