MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for BIOTENE DRY MOUTH LOZENGES (GLYCEROL, PECTIN) LOZENGE manufactured by Glaxosmithkline.
| Report Number | MW5090394 |
| MDR Report Key | 9193262 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-09-10 |
| Date of Event | 2012-02-28 |
| Date Added to Maude | 2019-10-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOTENE DRY MOUTH LOZENGES (GLYCEROL, PECTIN) LOZENGE |
| Generic Name | SALIVA, ARTIFICIAL |
| Product Code | LFD |
| Date Received | 2019-10-11 |
| Lot Number | W7021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | PO BOX 13398 RESEARCHTRIANGLE PARK NC 27709 US 27709 |
| Brand Name | BIOTENE ORAL BALANCE GEL (GLYCERIN) GEL |
| Generic Name | SALIVA, ARTIFICIAL |
| Product Code | LFD |
| Date Received | 2019-10-11 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | PO BOX 13398 RESEARCHTRIANGLE PARK NC 27709 US 27709 |
| Brand Name | BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) (GLYCERIN) MOUTH WASH |
| Generic Name | SALIVA, ARTIFICIAL |
| Product Code | LFD |
| Date Received | 2019-10-11 |
| Device Availability | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | PO BOX 13398 RESEARCHTRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-11 |