On march 09th, 2023, we have been informed an incident with ecg electrodes.Monitoring ecg electrodes (model: sbw601) had been used.The initial report stated "i am trying to find out more information about the electrodes i was supplied with for a 30 day cardiac monitor.I have attached a picture with product information.Do these electrodes contain any latex? i had an allergic reaction and i would like to identify if it is latex (known allergen), adhesive, or something else.The company who provided me with the electrodes could not answer my question." attached to these initial report a photo was provided showing a pouch of stable base ecg electrode lot number: 220715-0153.On march 13rd, 2023 we have received additional information in a filled in questionaire.A monitoring of arrhythmia was performed.The patient skin was described as normal and the general state also as normal.The medical history was described as "psoriasis, eczema, multiple allergies including latex, asthama".5 ecg electrode per use have been placed in the chest / abdomen area.In total the patient used 35 electrodes in 23 days.The patient described that the procedure should last for 30 days but was "shortened due to skin irritation and no available skin to apply electrodes that was intact / no rash.23 days total".The skin spreperation was described as cleaned, not shaven, not disinfected but has been dried and the rash was treated with "vtama, hydrocortisone".The ecg electrode were adhering to the patient skin and residues haves "sometimes - cleaned gently with soap to remove adhesive" "during and after 30 day monitor" in the chest, abdomen area "redness, rash-raised, itching then scabbed areas" have been detected "underneath adhesive and gel areas around edge in middle".The size was described as "1-2 inch areas where electrodes touched skin".The skin injury was treated by topical medications.No further details have been disclosed.
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