MAUDE Adverse Event Report: NEUROMD MEDICAL TECHNOLOGIES NEUROMD; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number NONE

Device Problem Unintended Movement (3026)

Patient Problems Skin Burning Sensation (4540); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2021

Event Type  Injury  

Event Description

I have been having problems with the neuromd device.Multiple times i felt a strong burn/shock sensation.Plus, the device stimulation tappers off before it should.I have spoken three times to their customer service reps.First time they admitted there was a bad part in the device and sent me a new one.Received that and now the same thing is happening again rep only tells me it's because the gel pad isn't stuck on my back will enough.To try another pad.The pads are (b)(6) for 3 of them, i can't throw away a pad after 3 uses.They say the pads last for 20 or so uses.The rep isn't helpful.I feel like a guinea pig.I highly doubt they are keeping a complaint file.The burn/ shock really hurts.Please check them out.This burn/shock has happened about 4 times now.It is the second time a part has failed.They deny it is failing.Fda safety report id # (b)(4).

• Brand Name: NEUROMD
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): NEUROMD MEDICAL TECHNOLOGIES; 18201 collins ave 4309a ; sunny isles beach, FL 33160
• MDR Report Key: 11541707
• MDR Text Key: 241924431
• Report Number: MW5100155
• Device Sequence Number: 1
• Product Code: GZJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NONE
• Device Catalogue Number: NONE
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR