MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for VITAGENE DNA TEST manufactured by Vitagene.
[174500474]
I have never reported to fda medwatch before. I actually have multiple genomics results that the fda may be interested in here: (b)(6) however, this is specifically about vitagene, where i was concerned about the number of supplements recommended (one of which i did have a mild adverse reaction to l-theanine, even with the assumption that i should test 1 new supplement at a time): (b)(6). Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092056 |
| MDR Report Key | 9558943 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-07-11 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAGENE DNA TEST |
| Generic Name | DNA GENETIC ANALYZER |
| Product Code | PCA |
| Date Received | 2020-01-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VITAGENE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |