MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for ELECTRONIC MUSCLE STIMULATOR manufactured by Miha Bodytec.
[71613643]
I am a member of (b)(6) ((b)(6)), an exclusive private club based in (b)(6). The club has approximately 10 electronic muscle stimulation (ems) devices manufactured by miha bodytec used during personal training sessions. I recently had a session with the (b)(6) personal trainer, (b)(6), and have since experienced severe nerve damage. I just learned that the ems machines the (b)(6) uses have not been approved by the fda for sale or business use in the u. S. As such, the devices must have been illegally imported since they cannot be purchased in the u. S. My concern is someone else being severely injured or worse. The (b)(6) is openly marketing ems sessions to all of its members.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068797 |
| MDR Report Key | 6450615 |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-03-03 |
| Date Added to Maude | 2017-03-31 |
| 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 | ELECTRONIC MUSCLE STIMULATOR |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2017-03-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIHA BODYTEC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-30 |