Initial information regarding this serious unsolicited device case from the united states was received from a healthcare professional reporter (pharmacist) on (b)(4) 2016.This case involves a patient of unknown demographics who had a serious skin reaction, unknown duration after starting smart relief tens therapy (icy hot smart relief tens therapy).Relevant past medications, medical history or concomitant medications were not 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).The patient had a serious skin reaction, unknown time after starting the use of smart relief tens therapy (onset date: unknown) and the reporter was trying to determine the ingredient in the product that caused the event.Action taken: unknown.Information on corrective treatment was not provided.Outcome: unknown.This case was assessed as serious due to medically significant event of "had a serious skin reaction".
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Initial information regarding this serious unsolicited device case from the united states was received from a healthcare professional reporter (pharmacist) on (b)(6) 2016.This case involves a patient of unknown demographics who had a serious skin reaction, unknown duration after starting smart relief tens therapy (icy hot smart relief tens therapy).Relevant past medications, medical history or concomitant medications were not 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).The patient had a serious skin reaction, unknown time after starting the use of smart relief tens therapy (onset date: unknown) and the reporter was trying to determine the ingredient in the product that caused the event.Action taken: unknown.Information on corrective treatment was not provided.Outcome: unknown.Qa review was performed and investigation findings were reported as "the device history files were reviewed at the time of the complaint for any anomaly, deviation or investigation, documented or otherwise that might result in any type of complaint against the lot.No evidence of root cause was found in the device history files." this case was assessed as serious due to medically significant for the event of "had a serious skin reaction".Additional information was received on 29-jan-2016: qa review was added.Text amended accordingly.
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