MAUDE Adverse Event Report: HEALTHMATE FOREVER LLC ELECTRONIC PULSE MASSAGER; TENS UNIT

Model Number YK15AB

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 03/26/2016

Event Type  Injury  

Event Description

I have received shock therapy at a health clinic for cubital tunnel syndrome.They suggested i get a device with the same shock therapy concept.I got this because it was supposedly fda approved.The first and lowest setting was already stronger and painful to use.I gave it the benefit of the doubt and tried it on my thigh and still the lowest setting was too much.My wife tried this, (b)(6), and she cried the moment it was turned on.This product is dangerous and i have no idea how it has fda approval or this many sales without being shutdown.I have had nerve pains that have been lingering for 2 days after using that product.

• Brand Name: ELECTRONIC PULSE MASSAGER
• Type of Device: TENS UNIT
• Manufacturer (Section D): HEALTHMATE FOREVER LLC
• MDR Report Key: 5553729
• MDR Text Key: 42267450
• Report Number: MW5061504
• Device Sequence Number: 1
• Product Code: NGX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: YK15AB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 118