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Model Number 381370056355 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Contact Dermatitis (4546)
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Event Type
Injury
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Manufacturer Narrative
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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.Age at time of event, weight, and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand tru stay plastic bandages 60ct usa 381370056355 381370056355usd, 381370056355usd, lot number 2641b.Udi #: (b)(4); upc #: 381370056355; lot #: 2641b; exp date: na.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.A review of the device history records has been requested.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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Event Description
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A male consumer experienced an adverse event with band aid brand tru stay plastic bandage.Consumer states that contact dermatitis was developed a day after he used the product in (b)(6) 2022 for wound care due to small injury.Consumer used a triamcinolone acetonide cream as prescribed by dermatologist.Consumer states that he is still experiencing same symptoms.
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Manufacturer Narrative
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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 an 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.H4, h6: 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 september 21,2022.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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