Model Number TVO01 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076)
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Event Type
Injury
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Manufacturer Narrative
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As neither a lot number nor samples have been made available to us, no analyses could be performed so far.The involved device has not been made available to us.No information on the patient, skin type, the skin preparation, state of skin, whether any medication was being taken, which might have a skin weakening effect and details of the use like the duration of wearing, how often the electrodes were changed was provided.Also no information was provided if and how the skin reaction had to be treated afterwards.We have requested further information.We will relay any further information in a follow up report.
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Event Description
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On august 06th, 2020 we have been informed about an incident involving ecg electrodes at a pharmacy located in a university medical center (b)(6).A monitoring procedure was performed using ecg electrodes (model skintact t-vo01) and a spiderflash-t afib device.The initial reporter provided the following information: "a patient undergoes a continuous electrocardiogram for seven days (with the spiderflash-t afib device).She used the skintact® t-vo01 offset ecg electrodes but developed an allergic reaction to the adhesive ring (she changes the electrodes if she takes a shower or bath).Which alternative electrode is compatible with the device for the described use and sensitive skin, avoiding the adhesive ring." no information about the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us.
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Manufacturer Narrative
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As neither a lot number nor samples have been made available to us, no analyses could be performed so far.The involved device has not been made available to us.No information on the patient, skin type, the skin preparation, state of skin, whether any medication was being taken, which might have a skin weakening effect and details of the use like the duration of wearing, how often the electrodes were changed was provided.Also no information was provided if and how the skin reaction had to be treated afterwards.After several requests we have been informed that: "i've checked with the patient.It was a light and local allergy to the electrodes, but she doesn't want to give more information about this case or her personal data." no conclusion can be drawn what might have caused the patient problem.We therefore consider the investigation closed.
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Event Description
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On (b)(6) 2020 we have been informed about an incident involving ecg electrodes at a pharmacy located in a university medical center (unisanté) in lausanne, switzerland.A monitoring procedure was performed using ecg electrodes (model skintact t-vo01) and a spiderflash-t afib device.The initial reporter provided the following information: "a patient undergoes a continuous electrocardiogram for seven days (with the spiderflash-t afib device).She used the skintact® t-vo01 offset ecg electrodes but developed an allergic reaction to the adhesive ring (she changes the electrodes if she takes a shower or bath).Which alternative electrode is compatible with the device for the described use and sensitive skin, avoiding the adhesive ring." no information about the patient, how the skin was prepared and if and how the injury was treated have been disclosed to us.
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Search Alerts/Recalls
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