Devices associated with this event have been received on 31aug2022.Due to the allegation of contamination that the package may have been in contact with mrsa, the package cannot be opened and will be disposed of according to local biohazard laws.There is no allegation or evidence of a device malfunction.It was identified that the patient was using the lead wire adapter (lwa) which utilized a 3rd party manufactured electrode.This is the accessory that makes continuous contact with the patient and is likely the cause of the skin irritation.Braemar devices are not known to cause methicillin resistant staphylococcus aureus(mrsa).It has been confirmed that the patient did not follow instructed skin care preparation/regiment before placing the electrode on their skin.Biotel heart distribution follows procedure for cleaning before being shipped to patients.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.
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