Device was used for treatment, not diagnosis.Patient identifier, age at time of event, sex, weight, and ethnicity and race were not provided for reporting.This report is for one (1) bab tough strips 20s usa 381370044086, 8137004408usa.Lot # is not available.Udi # is (b)(4).Device is not expected to be returned for manufacturer review/investigation.Device evaluation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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A consumer reported an event with bab tough strips.Consumer stated that within minutes of the use of bandage and allergic reaction occurred.The consumer experienced itching and the next day had a rectangle on skin that was the size and shape of the bandage.Consumer sought medical attention from a health care professional, a dermatologist, as the rectangle became an inflamed, itchy rash.Eight days later the consumer is still experiencing symptoms.
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