A1 & a4-a6: not provided.E1 reporter: not provided.E2-e3: it is unknown if the reporter was a health professional.-h10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.The instructions for use states, 3m¿ ecg monitoring electrodes, foam diaphoretic, 2228 are disposable, intended for single use, and has been tested for up to 3 days wear.For proper skin management and to minimize skin irritation: avoid placing an electrode on an irritated skin site.Do not abrade a skin site more than one time.Avoid removing electrodes frequently and/or reapplying to the same skin site.Avoid placing electrodes on skin still wet from an alcohol wipe (dry thoroughly).Assess electrode sites periodically.
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A 6-month-old male patient was admitted to hospital ecg monitoring was performed with 3m red dot electrodes, 2228, lot 2025-01 li.Mid-morning the same day, a 2x2cm skin rash higher than the skin surface with localized redness and swelling appeared at the electrode application site.The electrodes were replaced/applied to a different site and erythromycin ointment was applied on the affected area.
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