MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for GO FLOW manufactured by Unknown.
[46085226]
I used this device according to the instructions on the box. The instructions were vague, and in my view incomplete. One attaches electrified pads to the scalp and to the shoulder in order to improve brain functioning. The pad on my should burned my skin, a 3rd degree burn. This device is from the website "(b)(6)", a (b)(6) company which has locations in the us. The addresses are: (b)(6). Purchase date: (b)(6) 2016. Document number (b)(4). Report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062499 |
| MDR Report Key | 5684493 |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-02 |
| Date Added to Maude | 2016-05-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | GO FLOW |
| Generic Name | BRAIN STIMULATOR |
| Product Code | JXK |
| Date Received | 2016-05-24 |
| Model Number | GO FLOW |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-24 |