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) bab tough strips waterproof 20s usa 381370048336 8137004833usa 8137004833usa, lot number 0952b.D4: udi #: (b)(4).Upc #: 381370048336, lot #: 0952b and 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 april 4, 2012.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00031.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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Consumer reported an event with band-aid waterproof tough strips.The consumer had a cut on her arm and used the band aid for wound.On (b)(6) 2022, when the consumer tried to pull it off, her skin came right off.It was reported that consumer used one or two bandages each time.The consumer was still experiencing symptoms while reporting this event.Consumer visited urgent care where she was prescribed unknown antibiotics for treatment and stated that she was admitted to the hospital.This is two of two medwatches being submitted as two devices were involved in this event.See medwatch 8041154-2022-00031.The same patient is represented in each medwatch.
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