MAUDE Adverse Event Report: MIHA BODYTEC ELECTRONIC MUSCLE STIMULATOR; STIMULATOR, MUSCLE, POWERED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Nerve Damage (1979)

Event Date 03/03/2017

Event Type  Injury  

Event Description

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.

• Brand Name: ELECTRONIC MUSCLE STIMULATOR
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): MIHA BODYTEC
• MDR Report Key: 6450615
• MDR Text Key: 71613643
• Report Number: MW5068797
• Device Sequence Number: 1
• Product Code: IPF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE.; RX MEDS: NONE.
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 75