Investigation into the reported skin irritation does not suggest the issue is attributable to the device.While skin irritation is a known inherent risk of the device, communication with the patient suggests the most likely cause of the reported issue is user error.Clinical ref.Manual (nlb0020) application instructions, step 3b., reads ¿applying pressure, abrade the entire area using 40 broad strokes¿.Communication with the patient indicates they were abraded in excess of 40 times.In addition, the clinical ref.Manual also indicates the following warnings: ¿do not use the zio xt patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies.Patient may experience skin irritation¿ and ¿if skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio xt patch from the patient¿s chest.¿ per the patient, the reported skin irritation occurred following the skin preparation process, prior to device application.
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