MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-23 for AQUA FRESH-AQUA BLAST * manufactured by Glaxo Smith Kline.
[367705]
Purchased product but did not use it. It is a tooth-brush cleaner-16 tablets that are to be dissolved in hot tap water. Pt called company to find out ingredients, but they refused to give them. Pt does not want to use the product until they know what is in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003660 |
| MDR Report Key | 512470 |
| Date Received | 2003-12-16 |
| Date of Report | 2003-12-16 |
| Date Added to Maude | 2004-02-24 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUA FRESH-AQUA BLAST |
| Generic Name | TOOTH BRUSH CLEANER 16 TABLETS BLISTER PACK |
| Product Code | MDZ |
| Date Received | 2004-01-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | MG153 |
| ID Number | UPC053100004751 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 501481 |
| Manufacturer | GLAXO SMITH KLINE |
| Manufacturer Address | 1500 LITTLETON RD PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-16 |