Model Number FS501 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Type
Injury
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Manufacturer Narrative
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As neither customer samples nor the involved lot number were provided for this incident, no tests could be performed.Despite of repeated requests from us, the initial reporter was not able to supply us with more information on the involved product and on the treatment of the injury afterwards.No conclusion regarding the cause of the allergic reaction can be drawn.We will provide a follow up report when we will recieve additional information.
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Event Description
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On (b)(6) 2021, we have been informed about an incident with ecg electrodes at an ambulance in (b)(6).Monitoring ecg electrodes model medida fs501 have been used.We have been informed by the initial report that "as an emergency patient i received the electrodes mentioned above, now i have a strong allergic reaction".The patient also reported that "i still have red circles that itch after a week." no further information about the patient, the nature and duration of the procedure, how the skin was prepared and if and how the allergic reaction was treated have been disclosed to us despite of repeated requests.
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Event Description
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On (b)(6) 2021, we have been informed about an incident with ecg electrodes in an ambulance in germany.Monitoring ecg electrodes model medida fs501 have been used.We have been informed by the initial report that "as an emergency patient i received the electrodes mentioned above, now i have a strong allergic reaction".The patient also reported that "i still have red circles that itch after a week." no further information about the patient, the nature and duration of the procedure, how the skin was prepared and if and how the allergic reaction was treated have been disclosed to us despite of repeated requests.
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Manufacturer Narrative
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As neither customer samples nor the involved lot number were provided for this incident, no tests could be performed.Despite of repeated requests from us, the initial reporter was not able to supply us with more information on the involved product and on the treatment of the injury afterwards.We have been informed on (b)(6) 2021 that: "the allergic reaction was gone about 1 week after.Today [the patient] is fine again." as no further information was provided despite repeated requests no conclusion regarding the cause of the allergic reaction can be drawn.We therefore close the complaint.
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Search Alerts/Recalls
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