MAUDE Adverse Event Report: SANOFI AVENTIS U.S. LLC ICY HOT SMARTRELIEF TENS THERAPY BACK STARTER KIT; NUH

Lot Number 15G115

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 07/01/2015

Event Type  Injury  

Event Description

Burns [burns third degree] ([device use issue]).Blisters [blister].Scabs [scab].Expired device used [expired device used].Case narrative: initial information received on 08-jun-2018 regarding an unsolicited valid serious case received from a consumer from united states.This case involves female patient who experienced burns, blisters and scabs, while she was using of medical device smart relief tens therapy [icy hot smart relief tens therapy back starter kit and expired device was used.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using icy hot smart relief tens therapy back starter kit (smart relief tens therapy) dosage unknown (lot - 15g115 expiry date: 30-sep-2017 (expired device used).The patient developed an event of a serious burns (burns third degree) blisters (burn blister), scabs (scab).The patient mentioned that he has titanium rods in his back (device use issue) and he was informed that use of smart relief tens therapy was not recommend to customers with any metal implants, rods or cardiac pacemakers (device use issue).Seriousness criteria: medically significant for all except expired device used.It was not reported if the patient received a corrective treatment.Outcome: not applicable for device use issue; unknown for all other events.Qa results received on 03-aug-2018 from the qa department: lot batch number: 15g115, expiry date: 30-sep-2017, sample status: not available (device not returned).Qa findings revealed: a thorough investigation ((ihsr, capa protocol and review of (b)(4) [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 smartrelief is a tiny fraction of the limits in the fda guidance.The complete investigation is located in the device files.It was also reported that the consumer used the device in the presence of titanium rods in his back.The warnings on the carton of the device state, do not use this device under any circumstance if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.The consumer also reported that when they were sweating, the pad seemed to be melting completely.If the gel becomes over-hydrated due to moisture on the skin or application of other topicals, it may begin to change consistency and peel away from the pad.Additionally, the provided lot number (15g115) indicates an expiry date of 9/30/2017.Devices are not tested for safety or efficacy beyond date of expiry.The coa for electrode lot b-14-08-07a confirmed that all inspection items were passed.Device return is not expected at this time; therefore, investigation cannot proceed.Additional follow up information received on 03-aug-2018 from qa department: qa findings received.Additional event - expired device added.Text amended accordingly.

Event Description

Burns [burns third degree] ([device use issue]).Blisters.Scabs.Expired device used.Case narrative: based on the amendment received on 09-jan-2019, additional seriousness criteria intervention required was marked.Initial information received on 08-jun-2018 regarding an unsolicited valid serious case received from a consumer from united states.This case involves female patient who experienced burns, blisters and scabs, while she was using of medical device smart relief tens therapy [icy hot smart relief tens therapy back starter kit and expired device was used.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using icy hot smart relief tens therapy back starter kit (smart relief tens therapy) dosage unknown (lot - 15g115 expiry date: 30-sep-2017 (expired device used).The patient developed an event of a serious burns (burns third degree) blisters (burn blister), scabs (scab).The patient mentioned that he has titanium rods in his back (device use issue) and he was informed that use of smart relief tens therapy was not recommend to customers with any metal implants, rods or cardiac pacemakers (device use issue).Seriousness criteria: medically significant and intervention required for all except expired device used.It was not reported if the patient received a corrective treatment.Outcome: not applicable for device use issue; unknown for all other events.Qa results received on (b)(6) 2018 from the qa department: lot batch number: 15g115, expiry date: 30-sep-2017, sample status:not available (device not returned) qa findings revealed: a thorough investigation (richard willis, 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 smartrelief is a tiny fraction of the limits in the fda guidance.The complete investigation is located in the device files.It was also reported that the consumer used the device in the presence of titanium rods in his back.The warnings on the carton of the device state, do not use this device under any circumstance if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device.The consumer also reported that when they were sweating, the pad seemed to be melting completely.If the gel becomes over-hydrated due to moisture on the skin or application of other topicals, it may begin to change consistency and peel away from the pad.Additionally, the provided lot number (15g115) indicates an expiry date of 9/30/2017.Devices are not tested for safety or efficacy beyond date of expiry.The coa for electrode lot b-14-08-07a confirmed that all inspection items were passed.Device return is not expected at this time; therefore, investigation cannot proceed.This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module vi of the good pharmacovigilance practices.The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.Additional follow up information received on 03-aug-2018 from qa department: qa findings received.Additional event expired device added.Text amended accordingly.

• Brand Name: ICY HOT SMARTRELIEF TENS THERAPY BACK STARTER KIT
• Type of Device: NUH
• Manufacturer (Section D): SANOFI AVENTIS U.S. LLC; 55 corporate drive; bridgewater NJ 08807
• MDR Report Key: 8197646
• MDR Text Key: 131489855
• Report Number: 3003496686-2018-00001
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2017
• Device Lot Number: 15G115
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention