MAUDE Adverse Event Report: CHATTEM / SANOFI US SERVICES INC. ICYHOT SMART RELIEF TENS THERAPY; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Model Number SMARTRELIEF 1.0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2020

Event Type  malfunction  

Event Description

The tens unit doesn't work properly, and in researching it, this seems to be a common occurrence with the icyhot smart relief system.You are to snap the power unit onto adhesive pad, but while one snaps and goes on fine, the other side doesn't match up quite right so you have to move it around a little to get it to snap on.This put a small wrinkle in the pad by both snaps, very slightly.When you place the pad on the back or hip, instead of the stimulation of nerves that should be felt, there is a thumping feeling like someone tapping finger on you coupled with intermittent stimulation sensation.Trying to use the button to increase to the 63 settings also doesn't work because it feels like the thumping takes the setting i tried to use back down to zero over and over.I have tried this 3 times today and each time this has happened.This is the main complaint with this tens system in reading reviews on various places, that the unit electrode and power system doesn't work correctly.Fda safety report id# (b)(4).

• Brand Name: ICYHOT SMART RELIEF TENS THERAPY
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): CHATTEM / SANOFI US SERVICES INC.
• MDR Report Key: 10000746
• MDR Text Key: 189171195
• Report Number: MW5094268
• Device Sequence Number: 1
• Product Code: NUH
• UDI-Device Identifier: 00041167080450
• UDI-Public: 041167080450
• Combination Product (y/n): N
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: SMARTRELIEF 1.0
• Device Catalogue Number: 0042298-03
• Device Lot Number: 19L108
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 112