JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND HYDROSEAL BANDAGES LARGE; DRESSING, WOUND, OCCLUSIVE
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Model Number 381371174010 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 10/13/2022 |
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 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.Patient age: 35, weight and ethnicity and race were not provided for reporting.This report is for one (1) band aid brand hydroseal bandages large 6ct (b)(4).Udi #: (b)(4).Upc # (b)(4).Expiration date: na.Lot #: 1182c.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.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00047.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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Event Description
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A female consumer reported an event with large band aid brand hydroseal bandages.She reported that she had a blister on the heel and used band-aid hydroseal bandages on (b)(6) 2022.Consumer stated that she went to emergency room (er) on (b)(6) 2022 and was admitted to the hospital due to anaphylactic reaction to the bandage.Symptoms have improved and the consumer was discharged on same day on (b)(6) 2022.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00047.The same patient is represented in each medwatch.
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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.This report is for one (1) band aid brand hydroseal bandages large 6ct usa 381371174010 8137117401usa.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 february 16, 2022.This is one of two follow up medwatches being submitted as two devices were involved in this event.The same patient is represented in each follow up medwatch.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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