Retained samples of the concerened lot batch of model sbt601 have been inspected visually.Mechanical tests were performed on 3 retained samples.All tested samples were found to perform within limits.No faults could be detected.We have requested for further information on the patient, skin type, state of skin, whether any medication was being taken, which might have a skin weakening effect, details of the use and have been informed that "no additional information of any kind" was available.We therefore consider the investigation and the report closed.
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On (b)(6) 2023 , we have been informed about 26 incidents with ecg electrodes.Monitoring ecg electrodes (model sbw601 and sbt601) had been used with bodyguardian mini+ and bodyguardian one devices.The initial reporter has attached for each patient an incident summary.In total, there were 26 reports covering a period from (b)(6) thru (b)(6).No medical intervention was necessary for 25 incidents.For 1 incident a medical intervention was needed to treat the injury.The reportable event disclosed that the patient's skin was prepered using saline wipes before applying the ecg electrodes.The patient experienced "redness, peeling skin, open sores".The ecg electrodes have been removed "gently rolled dry".It was also reported that the patient decided to pause the study and decided that they will reconnect once the reported skin irritation heals.It was stated that a medical intervention with neosporin was used to treat the injury and that the patient decided to pause the study and decided that they will reconnect once the reported skin irritation heals.No further information was provided.
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