MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-18 for NU SKIN PHARMANEX manufactured by Nuskin.
[2251306]
My dr has been advertizing the pharmanex biophotonics scanner in his office. The company, nu skin pharmanex, claims that the device can determine whether a pt is receiving an adequate supply of antioxidants. The website, http://www. Pharmanexmd. Com/, further indicates that low antioxidant levels are associated with elevated risk of chronic disease and death. It does not seem that this device has fda approval. The product has apparently been featured on the (b)(4), reaching a wide audience.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022720 |
| MDR Report Key | 2306821 |
| Date Received | 2011-10-18 |
| Date of Report | 2011-10-18 |
| Date Added to Maude | 2012-01-19 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NU SKIN PHARMANEX |
| Generic Name | BIOPHOTONICS SCANNER |
| Product Code | HCC |
| Date Received | 2011-10-18 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUSKIN |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-18 |