Device was used for treatment, not diagnosis.Udi number: (b)(4)/ upc = (b)(4)/ expiration date = na/ lot number = not reported.Device is not expected to be returned for manufacturer review/investigation.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 a lot number.(b)(4); labeling design - part of recall number z-1203-2018 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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This incident involves a (b)(6) male consumer using a band-aid brand first aid secureflex wrap (2 x 2.5yd).The consumer reported using a band-aid brand first aid secureflex wrap to secure a traction device on his leg.The consumer started and stopped usage of the product on (b)(6) 2018 and topically applied the wrap once for 6-7 hours.The consumer reported the product irritated his skin, made it scratchy, stinging, and red.The consumer¿s symptoms reduced after he stopped using the product.The consumer did self treat by applying bacitracin to the area.
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