The patient reported skin irritation with signs of secondary infection alleged to be caused by zio at.The patient was diagnosed with contact dermatitis and cellulitis and was prescribed treatment by their healthcare provider.Skin irritation is a known inherent risk of the device.Device manual warnings section read as follows: do not use the zio at patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies.Patient may experience skin irritation.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio at patch from the patient¿s chest.This event is being reported per 21 cfr 803 as a serious injury.This report does not constitute an admission by irhythm that the product described in this report has any defects, or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.
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