MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-07-21 for ALZHEIMALERT CLIA ID#21D0917550 * manufactured by Nymox.
[15183467]
We have serious doubts about the scientific background of the alzheimaltert test, sold by nymox. The detected protein can not exist as published. Please see the paper: kriegs jo, schmitz j, makalowski w, brosius j. Does the ad7c-ntp locus encode a protein? Biochim biophys acta. 2005 jan 21; 1727-1-:1-4. Epub 2004 dec 31.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1036152 |
| MDR Report Key | 752392 |
| Date Received | 2005-07-28 |
| Date of Report | 2005-07-20 |
| Date Added to Maude | 2006-08-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | ALZHEIMALERT |
| Generic Name | * |
| Product Code | LNJ |
| Date Received | 2005-07-21 |
| Model Number | CLIA ID#21D0917550 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 740192 |
| Manufacturer | NYMOX |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-28 |