MAUDE Adverse Event Report: CHATTEM, INC. ICY HOT SMART RELIEF TENS THERAPY; TRANSCUTANEOUS NERVE STIMULATOR

Lot Number 14F122

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Peeling (1999); Swelling (2091)

Event Type  Injury  

Event Description

Initial info regarding unsolicited serious device case from united states was received from a pt on (b)(6) 2014.This case involves a female pt of unk age who experienced blister, burning and skin peeling (reported as: it took the skin off in one spot), unk duration after starting smart relief tens therapy (icy hot smart relief tens therapy).Concomitant medications: not provided.Med history: diabetes and some nerve damage.On an unk date the pt commenced therapy with smart relief tens therapy (lot/batch number 14f122, expiration date 30 june 2016, dosing details were not provided) for back pain, arthritis and disc problems in back.Pt stated that she used the device and maybe it was turned up too high; it felt good when it was no her back and didn't hurt (wore the product for a 30 minute session and when the session ended she took the device off) but when she got out of the shower she noticed what looked like a blister on her back (onset date was not specified).She stated, "i am fat and have diabetes so my skin is thin.I also might have some nerve damage on that side (med history) which may be why i couldn't feel it burning me (onset date not specified").The pt also reported that the device took the skin off in one spot (onset date not specified) as it must have been too high.Pt had trouble turning the device on and turning it up while it is on her back because she could not reach around.Also, on an unspecified date when the pt was turning on the device, she couldn't feel anything and after you turn it off it went back to 1.Action taken: unk.Info on corrective treatment was not provided.Outcome was unk for all events.The events of blister and burning were important med events.Additional info was received on (b)(6) 2014 from pt: it was reported the pt wore the product for a 30 minute session and when the session ended she took the device off.Sanofi co comment dated 12 december 2014: as per the updated info in the follow up version the previous med assessment of the case is retained as unaltered because no relevant info which may impact the previous med assessment of the case has been received.Sanofi comment dated 10 december 2014: although the causal association of co suspect icy hot smart relief tens therapy cannot be denied for the event of burning and blister, at the same time we cannot negate the fact that the pt was using the device at very high intensity and could not feel the damage owing to this preexisting condition of nerve damage, which eventually contributed to the onset of the adverse event.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM, INC.; chattanooga TN
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4337773
• MDR Text Key: 5201135
• Report Number: 1022556-2014-69373
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2016
• Device Lot Number: 14F122
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2014
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other