MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-02-28 for BIOTENE ORAL RINSE manufactured by Glaxosmithkline.
[2521698]
This case was reported by a consumer and described the occurrence of taste absent in a (b)(6) male pt who received glucose oxidase+lactoferrin+lactoperoxidase+lysozyme (biotene oral rinse) for an unk drug indication. A physician or other health care professional has not verified this report. On an unk date, the pt started glucose oxidase+lactoferrin+lactoperoxidase+lysozyme. At an unk time after starting glucose oxidase+lactoferrin+lactoperoxidase+lysozyme, the pt experienced taste absent and taste alteration. At the time of reporting, the events were unresolved. F/u was received on (b)(4) 2012 which upgraded the case to serious: the consumer called in and reported the originally reported adverse events of lost sense of taste and altered sense of taste and was not due to using the originally reported product of biotene dry mouth oral rinse. It was determined when his wife who is a nurse was concerned it may be something more serious and he went to the hosp where they did confirm he was having signs of a stroke coming on.
Patient Sequence No: 1, Text Type: D, B5
[9604607]
Biotene oral rinse is mfg in (b)(4), in the us, and neither the product nor lot number for this product is available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2022474-2012-00003 |
| MDR Report Key | 2474227 |
| Report Source | 04 |
| Date Received | 2012-02-28 |
| Date of Report | 2012-02-27 |
| Date Mfgr Received | 2012-02-21 |
| Date Added to Maude | 2012-07-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | P.O. BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | LACLEDE, INC. |
| Manufacturer Street | 2103 EAST UNIVERSITY DR. |
| Manufacturer City | RANCHO DOMINGUEZ CA 90220 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTENE ORAL RINSE |
| Generic Name | GLUCOSE OXIDASE+LACTOFERRIN+LACTOPEROXID |
| Product Code | NTO |
| Date Received | 2012-02-28 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-28 |