As neither a lot number nor samples have been made available to us, no analyses could be performed.No information how the skin was prepped has been provided.It is also unclear whether "hurt skin" constitutes injuries and whether they had to be treated.It was not possible to receive this information despite repeated requests.Our distributor informed us that "the problem was not from the ecg electrodes.The main problem was from the user(nurse).(.) because this is nothing to do with electrodes therefore we closed the complain by ourselves." it is unclear whether the user has followed the instruction for use.But the ifu explicitly states the warning: "after use, carefully remove the electrode using one hand whilst supporting the skin beneath it with the other.Ripping off the electrode or peeling it off quickly may damage the skin.Exercise particular caution if the skin is exceptionally sensitive, especially with children but also with elderly patients, diabetics, or patients on a prolonged course of certain medications known to cause dermatological side effects." we therefore consider the investigation and the complaint closed.
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