MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-02-05 for PHARMANEX * manufactured by Pharmanex, Inc..
[287347]
The md believes that the device requires fda approval before marketing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1027583 |
| MDR Report Key | 443883 |
| Date Received | 2003-02-05 |
| Date Added to Maude | 2003-02-25 |
| 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 | 0 |
| Reporter Occupation | UNKNOWN |
| 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 | PHARMANEX |
| Generic Name | BIOPHOTONIC SCANNER |
| Product Code | HCC |
| Date Received | 2003-02-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 432860 |
| Manufacturer | PHARMANEX, INC. |
| Manufacturer Address | 10 EAST SOUTH TEMPLE #900 SALT LAKE CITY UT 84133 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-02-05 |