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Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
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Event Date 08/22/2022 |
Event Type
Injury
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Event Description
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The patient reported probable contact dermatitis, erythema, itching, rash and blisters.This report is being submitted in response to mw5111712.
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Manufacturer Narrative
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Skin irritation is a known inherent risk of the device.Clinical ref.Manual (nlb0020) warnings state the following: 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.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio xt patch from the patient¿s chest.
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Search Alerts/Recalls
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