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U.S. Department of Health and Human Services

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

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CHATTEM / SANOFI US SERVICES INC. ICYHOT SMART RELIEF TENS THERAPY STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
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).
 
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Brand NameICYHOT SMART RELIEF TENS THERAPY
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
CHATTEM / SANOFI US SERVICES INC.
MDR Report Key10000746
MDR Text Key189171195
Report NumberMW5094268
Device Sequence Number1
Product Code NUH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model NumberSMARTRELIEF 1.0
Device Catalogue Number0042298-03
Device Lot Number19L108
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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