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

Lot Number 15D108

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Upon internal review on 18-dec-2015, medical reassessment was made to upgrade the case from 'nonserious' to 'serious', since the previously reported event "skin actually burnt" was reassessed as serious- important medical event.Initial information regarding this unsolicited device case from the united states was received from a patient on (b)(6) 2015.This case involves a female patient of unknown age whose skin actually burnt an unspecified time frame after using smart relief tens therapy (icy hot smart relief tens therapy).No relevant past medications, medical history, concurrent conditions or concomitant medications were reported.On an unspecified date the patient started using smart relief tens therapy for an unreported indication (lot/ batch number and expiration date: not provided).It was reported that the patient used the product on the hip area on low and did not use for the full amount of 30 minutes.However her skin actually burnt (onset date and latency: unknown) and she needed to seek medical help.The patient suggested putting some kind of warning label mentioning "to be very cautious when using this device if your skin is sensitive".She also wondered if the device was faulty.Action taken: unknown.Outcome: unknown.Upon internal review on 18-dec-2015, medical re-assessment was made to upgrade the case from 'non-serious' to 'serious', since the previously reported event "skin actually burnt" was reassessed as serious- important medical event.

Event Description

Upon internal review on 18-dec-2015, medical reassessment was made to upgrade the case from 'nonserious' to 'serious', since the previously reported event "skin actually burnt" was reassessed as serious- important medical event.Initial information regarding this unsolicited device case from the united states was received from a patient on 28-oct-2015.This case involves a female patient of unknown age whose skin actually burnt an unspecified time frame after using smart relief tens therapy (icy hot smart relief tens therapy).No relevant past medications, medical history, concurrent conditions or concomitant medications were reported.On an unspecified date the patient started using smart relief tens therapy for an unreported indication (lot/batch number: 15d108 and expiration date: 28-feb-2017).It was reported that the patient used the product on the hip area on low and did not use for the full amount of 30 minutes.However her skin actually burnt (onset date and latency: unknown) and she needed to seek medical help.The patient suggested putting some kind of warning label mentioning "to be very cautious when using this device if your skin is sensitive".She also wondered if the device was faulty.Action taken: unknown.Outcome: unknown.Upon internal review on 18-dec-2015, medical re-assessment was made to upgrade the case from 'non-serious' to 'serious', since the previously reported event "skin actually burnt" was reassessed as serious- important medical event.Qa review: description of investigation: received one tens unit serial number 1409161379597, one panasonic battery, and one electrode from lot 14082001 for evaluation.Upon visual inspection, the tens unit was in good condition.The unit was fully functional with both the received and a new battery; complete and consistent stimulation was present.No erratic operation from the control unit was noted.The electrode was in good condition and stored on a clear, protective sheet; it was clean, not missing gel, and sticky.The left impedance readings were 600 ohm and 600 ohm, and the right impedance readings were 630 ohm and 600 ohm.Because of the severity of the burn claim, the pad was heavily investigated for hotspots; however, there were uniform impedance readings across various locations of the pad.Therefore, the electrode pad is not the reason that the consumer was experiencing issues.All device components were investigated and it can be confirmed that the adverse event that the consumer was experiencing was not due to any device malfunction.Therefore, no faults were found with this device.Final conclusion: no faults found with this device root cause: no faults found with this device additional information was received on 19-jan-2016: lot/batch number, expiry date added, qa review was also added.

• Brand Name: ICY HOT SMART RELIEF TENS THERAPY
• Type of Device: TRANSCUTANEOUS NERVE STIMULATOR
• Manufacturer (Section D): CHATTEM; 1715 west 38th street; chattanooga TN 37409
• Manufacturer Contact: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5365805
• MDR Text Key: 35922162
• Report Number: 1022556-2015-78222
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Lot Number: 15D108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other