MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-01 for NU SKIN GALVANIC SPA SYSTEM II manufactured by Nu Skin.
[1445465]
When doing a facial treatment with the nu skin galvanic spa system ii, i got several blood - red pimples on my face, which do not disappear. I may need medical treatment/intervention to remove them. Dates of use: (b) (6) 2009 -- (b) (6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014618 |
| MDR Report Key | 1595179 |
| Date Received | 2010-02-01 |
| Date of Report | 2010-02-01 |
| Date of Event | 2010-01-25 |
| Date Added to Maude | 2010-02-16 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NU SKIN GALVANIC SPA SYSTEM II |
| Generic Name | NU SKIN GALVANIC SPA SYSTEM II |
| Product Code | GZO |
| Date Received | 2010-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NU SKIN |
| Manufacturer Address | PROVO UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-02-01 |