JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND INFECTION DEFENSE LARGE ADHESIVE COVER WITH NEOSPORIN; TAPE AND BANDAGE, ADHESIVE
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Model Number 381370055679 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Contact Dermatitis (4546); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/03/2022 |
Event Type
Injury
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Event Description
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Female consumer reported an event with band aid bandage antibiotic extra large.On (b)(6) 2022, the consumer used the product to aid in the healing of a burn.On (b)(6) 2022, the consumer alleged that she crying in pain due do a bad reaction.A healthcare provider (hcp) was contacted about the experience.The hcp said it was contact dermatitis and prescribed betamethasone dipropionate for the treatment.The consumer also was using unknown steroid cream, extra gauze, and tape to attempt to heal symptoms.Consumer is still experiencing these 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 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.Patient weight, and ethnicity and race were not provided for reporting.This report is for one bab antibiotic extra large 8s usa 381370055679 8137005567usb lot number 0352b.Udi #: (b)(4).Upc #: (b)(4).Lot #: 0352b.Expiration date - 02/01/2024.Device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.(b)(4).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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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 february 4, 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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