ELECTRONIC MUSCLE STIMULATOR
Received Mar 30, 2017 · Event occurred Mar 3, 2017
Report MW5068797 · MDR key 6450615
Device
Generic name
Stimulator, Muscle, Powered
Manufacturer
Miha BodytecProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR
- Nerve Damage
- Nerve Damage
Narrative
Description of Event or Problem
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.