Device was used for treatment, not diagnosis.Patient date of birth, weight and ethnicity were not provided for reporting.This report is for one bab clear spots 50s usa 381370047087 8137004708usb.Udi #: (b)(4).Upc #: (b)(4), lot #: 3389b, exp date: na.Device is not expected to be returned for manufacturer review/investigation 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 december 4, 2019 (b)(4).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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A female consumer reported an event with bab clear spots 50s usa.The consumer applied one band-aid and alleged having a reaction to the adhesive on the left side of the face on (b)(6) 2020.Consumer visited dermatologist who confirmed allergic reaction.The consumer was prescribed an ointment for treatment.The consumer is still experiencing symptoms, such as, itching, redness, little bumps and swollen area.
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