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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

Initial information regarding this unsolicited case from united states was received on 22-jan-2017 from the patient.This case involves a female patient of unknown age who had terrible blisters on her back, an unknown duration after initiating treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy).No past drugs, relevant medical history, concurrent conditions or concomitant medications were reported.On an unspecified date, the patient started using smart relief tens therapy (frequency, lot/batch number and expiration date: unknown) for back pain.According to the patient, it released some of the pain.It was for back and hip.On an unknown date, the patient put it on her back and pushed the plus and sat in the chair.She immediately felt like something poking her in the back.She removed the patch and observed terrible blisters on her back (latency: unspecified).The patient had been in pain from this.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event.

Event Description

Initial information regarding this unsolicited case from united states was received on 22-jan-2017 from the patient.This case involves a female patient of unknown age who had terrible blisters on her back, an unknown duration after initiating treatment with smart relief tens therapy (icy hot smart relief tens back pain therapy).No past drugs, relevant medical history, concurrent conditions or concomitant medications were reported.On an unspecified date, the patient started using smart relief tens therapy (frequency, lot/batch number and expiration date: unknown) for back pain.According to the patient, it released some of the pain.It was for back and hip.On an unknown date, the patient put it on her back and pushed the plus and sat in the chair.She immediately felt like something poking her in the back.She removed the patch and observed terrible blisters on her back (latency: unspecified).The patient had been in pain from this.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event.Qa review findings: the consumer stated that they experienced painful blisters after using the device on their back.A thorough investigation ((b)(4), 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 at this time.Awaiting further correspondence and device return for additional investigation.Additional information was received on 25-jan-2017 from quality department, qa review finding added.Text amended accordingly.

• Brand Name: ICY HOT SMART RELIEF TENS BACK PAIN 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: 6289732
• MDR Text Key: 66157954
• Report Number: 1022556-2017-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• 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: 01/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2017
• 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