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

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.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY, PAIN THERAPY KIT
• Type of Device: ICY 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 Key: 5913389
• MDR Text Key: 53667214
• Report Number: MW5064424
• Device Sequence Number: 1
• Product Code: NUH
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2017
• Device Lot Number: B150319, 15F703
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR