MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for BIOTENE DRY MOUTH ORAL RINSE manufactured by Glaxosmithkline Consumer Healthcare Holdings (us) Llc.
[135610062]
I used biotene dry mouth wash last night and woke up to swollen gums and the inside of both lips and cheek. My tongue was fine. It's been 24 hours and it's still swollen to a degree. Is this product over the counter? Yes. Did the problem stop after the person reduced the dose or stopped taking or using the product? No. Date the person first started taking or using the product: (b)(6) 2019. Date the person stopped taking or using the product: (b)(6) 2019. I have dry mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083668 |
| MDR Report Key | 8301465 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-26 |
| Date of Event | 2019-01-25 |
| Date Added to Maude | 2019-02-04 |
| 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 | 0 |
| Brand Name | BIOTENE DRY MOUTH ORAL RINSE |
| Generic Name | SALIVA, ARTIFICIAL |
| Product Code | LFD |
| Date Received | 2019-02-01 |
| Lot Number | 8L168C |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |