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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANFONS COMPANY. DISTRIBUTED BY CHATTEN INC. ICY HOT SMART RELIEF TENS THERAPY, PAIN THERAPY KIT

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SANFONS COMPANY. DISTRIBUTED BY CHATTEN INC. ICY HOT SMART RELIEF TENS THERAPY, PAIN THERAPY KIT Back to Search Results
Lot Number B150319, 15F703
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Tingling (2171); Arthralgia (2355)
Event Date 07/22/2016
Event Type  Injury  
Event Description
I purchased the icy hot tens unit to use for arthritic knee pain. I carefully read and followed the instruction as directed. The skin on my knee was performed as stated in the package. Right knee. The first date i used it was (b)(6) 2016. I then placed the battery powered unit on the electrode as directed. The controls were adjusted by pressing the buttons and for increase and decrease in intensity. After feeling the tingling in my knee i lowered it for 20-30 minutes. I then removed the device and the electrode is directed. My knee was of normal color. The following morning (b)(6) 2016 upon arising i noticed a large purplish area. The area was exactly where the electrode had been the previous day. The tiny blood vessels in this area had burst, causing the large bruised like area. The area was tender to touch. I am on coumadin for a fib. There was nothing on package about mal using. There was no burns, redness and rash on the area. I took photos over a period of time to document this. I did not use the device again. I still have it in my possession. The condition of my skin prior to using was pink, warm, dry without bruising. My skin (illegible) was normal. The bruising and discoloration laster over one week.
 
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Brand NameICY HOT SMART RELIEF TENS THERAPY, PAIN THERAPY KIT
Type of DeviceICY HOT SMART RELIEF TENS THERAPY, PAIN THERAPY KIT
Manufacturer (Section D)
SANFONS COMPANY. DISTRIBUTED BY CHATTEN INC.
po box 2219
chattanuga TN 34409 0219
MDR Report Key5913389
MDR Text Key53667214
Report NumberMW5064424
Device Sequence Number1
Product Code NUH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/01/2017
Device Lot NumberB150319, 15F703
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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