MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-04 for ACTIPATCH manufactured by Bioelectronics.
[42490418]
Bioelectronics has not been cleared to sell their products over the counter in the usa. However, they have two sites overseas selling and shipping back to the usa. At checkout, they confirm you can buy in the usa. And they are promoting online to drive sales to them. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061532 |
| MDR Report Key | 5553878 |
| Date Received | 2016-04-04 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-04-01 |
| Date Added to Maude | 2016-04-07 |
| 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 | 0 |
| Brand Name | ACTIPATCH |
| Generic Name | ACTIPATCH |
| Product Code | ILX |
| Date Received | 2016-04-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOELECTRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-04 |