An (b)(6) consumer stated that they used band-aid kizu power pad plus big size 6ct ap (kkp), to treat a wound and became purulent.The consumer stated they used two kinds of kpp.The consumer stated they gotten the wound because they scratched their arm on a telephone pole about one week prior to this reporting.The consumer initially applied an adhesive tape manufactured by another company, but the skin on the tape part became irritated, so they changed it to kpp plus large.The consumer changed the product every day because a lot of lymph fluid was discharged.Consumer ran out of kpp plus large and purchased kpp large at a convenience store near their house.The consumer applied kpp large until the morning on the day of this reporting.The consumer stated they saw a physician in the morning on the day of this reporting and was told not to apply kpp because the wound became purulent.The consumer was prescribed an antibiotic.Consumer did not identify the antibiotic they were prescribed nor dosage and frequency.Consumer followed-up to see the physician again on (b)(6)2021.The consumer stated there was no problem because the wound already subsided.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2021-00047.The same patient is represented in each medwatch.
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Device was used for treatment, not diagnosis.Patient identifier, gender, weight and ethnicity were not provided for reporting.This report is for (band-aid kizu power pad plus big size 6ct ap 4901730180450 79606722apa 79606722apa).Device is not distributed in the united states, but is similar to device marketed in the usa ( band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).(b)(4).Upc #: 4901730180450.Expiration date: na.Lot #: ni.Device is not expected to be returned for manufacturer review/investigation g3: device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa 381371175338 8137117533usa 8137117533usa).Device evaluation/investigation 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.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2021-00047.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, an additional follow- up medwatch will be filed as appropriate.
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