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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Local Reaction (2035); Burning Sensation (2146)

Event Date 05/01/2017

Event Type  Injury  

Event Description

Initial information regarding this unsolicited case from united states was received on (b)(6) 2017 from the patient.This case involves a (b)(6) old male patient, who developed series of blisters and large patch of skin which appeared to be burned after receiving smart relief tens therapy (icy hot smart relief tens therapy).Past drugs, medical history and concomitant medications were not reported.On an unknown date, the patient started therapy with smart relief tens therapy at an unspecified frequency (lot/batch number and expiry date: unknown) for pain from arthritis and degenerative disc disease.Patient had used smart relief tens therapy for several years, and it was a great relief for patient's pain from arthritis and degenerative disc disease.About a month ago ((b)(6) 2017), patient had a series of blisters developed under a new replacement pad (latency: unknown).Patient let the blisters heal for about a week, then tried another new pad.Within two days he developed a large patch of skin which appeared to be burned (onset date: 2017 and latency: unknown).At the age of (b)(6), he did not use any medications, and would prefer not to begin now.However patient was in pain when he could not use his tens unit.Action taken: drug withdrawn nos.Corrective treatment: not reported.Event outcome: recovered from application site blister on unknown date and unknown for application site burning.Qa review: all retains are examined for correct packaging, seal, missing components, working control unit, legibility of lot numbers /expiration date, correct label and foreign matter.No anomalies were found that could contribute to this complaint.A thorough investigation ((b)(6), capa protocol and review of ihsr [2014]) has been done to investigate.The likelihood of the ihsr producing burns in some users.This investigation found that it is highly unlikely.For the smart relief to produce tissue trauma.The maximum current and power density calculated for the smart relief is a tiny fraction of the limits in the fda guidance.The complete investigation is located in the device files.Lot information was not provided and device return is not expected at this time; therefore, additional investigation is not possible.Pharmacovigilance comment: sanofi company comment dated 30-06-2017:this case concerns an elderly male patient who experienced application site burning and application site blister whilst being treated with smart relief tens therapy.The causal role of smart relief tens therapy cannot be ruled out, however this case lacks information regarding the condition of the skin at the contact area prior to applying the device leads (e.G., wet, dry, open wounds),concomitant.Medications and medical history for comprehensive assessment of the case.

• 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: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 6705177
• MDR Text Key: 79738965
• Report Number: 1022556-2017-00004
• 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
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR