Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes and admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.This report is for one (1) band-aid brand tru stay sheer large adhesive pad 10ct usa 381370047681 381370047681usa 381370047681usa, lot number-n/a.Udi #: (b)(4).Upc: 381370047681.Lot number: ni.Exp date: na.D10: device is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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.H6: e2402 refers to consumer "intentional misuse/off-label use" of the product.This is two of three medwatches being submitted as two devices were involved in this event.See medwatches 8041154-2022-00021, 8041154-2022-00022 & 8041154-2022-00023.The same patient is represented in each medwatch.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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