A1 & a4-a6 patient specifics: not provided.E2-e3 initial reporter: it is unknown if the reporter is a health professional.G2: report source: it is unknown if the reporter is 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¿ red dot¿ soft cloth monitoring electrode, 2238 are disposable, intended for single use, and has been tested for up to 3 days wear.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 38-year-old female allegedly experienced a rash and an itching sensation with the use of the 3m¿ red dot¿ soft cloth monitoring electrode, 2238 lot 2024-06 xc.The electrodes were subsequently removed, and an anti-allergic, fluoxetine ointment was applied.The symptoms subsequently resolved the same day.No additional information is available.
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