Device was used for treatment, not diagnosis.Patient identifier, weight, and ethnicity and race were not provided for reporting.This report is for band-aid breathable 16ct ap (b)(4).Device is not distributed in the united states.Band-aid breathable 16ct ap (b)(4) is similar to device marketed in the usa (bab sheer 1inx3in usa 38137004770 8137004770usa 8137004770usa).Udi #: (b)(4).Upc #: 6916999215513.Lot #: 200413 1813.Exp: na.Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa (band-aid breathable 16ct ap (b)(4).Device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on april 13, 2020.This is 2 of 2 med-watches being submitted, as it was unknown which band-aid product was involved in this event.See medwatch 1000599868-2021-00004.The same patient is represented in each medwatch.If information is obtained that was not available for this initial medwatch, an additional follow-up medwatch will be filed as appropriate.
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Consumer reported an event for pediatric consumer ((b)(6)old) using band-aid breathable ap for a skin scratch.The consumer purchased a bandage from the hospital on (b)(6) 2021 and took it home and applied it to the skin scratch of the consumer¿s right hand.Around noon time of (b)(6) 2021, the pediatric consumer had developed itchy skin and stopped using the bandage.Consumer visited a hospital for treatment.The consumer showed mild skin redness at the scratch site.The bandage was discontinued, and the patient and was given fluocinonide cream (to prevent infection and to accelerate healing) for application after examination.The consumer returned home and was told to keep it under observation.The consumer was followed up for discomfort.This is 2 of 2 med-watches being submitted, as it was unknown which band-aid product was involved in this event.See medwatch 1000599868-2021-00004.The same patient is represented in each medwatch.
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