[131489855]
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.
Patient Sequence No: 1, Text Type: D, B5