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Model Number 381371155675 |
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 Date 11/11/2023 |
Event Type
Injury
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Event Description
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A 33-year-old male consumer reported an event with band-aid tough strips all one size bandages.Consumer started using bandages on (b)(6) 2023 for cuts on legs and elbow.Consumer reported using three band-aids on left leg, one on right leg and one on left elbow.Consumer alleged that on (b)(6) 2023, consumer developed large weeping lesions/rash with swelling on legs and elbows from using this products.Consumer went to urgent care on (b)(6) 2023 and was told that consumer had cellulitis and was given antibiotics.Consumer was also told by practitioner that left leg is likely to scar due to the severity of the reaction.Consumer went on (b)(6) 2023 for a follow-up and it was determined that it was not cellulitis, but it was contact dermatitis, and was given oral steroids (prednisone) for the swelling and a topical ointment for the itch.Consumer is still not recovered at the time of reporting.This is 3 of 5 med-watches (bab 03- left leg) being submitted as five devices were involved in this event.See medwatch 8041154-2023-00029; 8041154-2023-00030; 8041154-2023-00032; 8041154-2023-00033.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.A4, a5: patient, weight, ethnicity and race were not provided for reporting.D1, d2, d3, d4: this report is for one (1) bab tough strips 1x3 1/4 in 60s usa (b)(4) usa, lot/ctrl # 3422b.D4: udi #: (b)(4).Upc # (b)(4).Lot # 3422b.Expiration 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 has been requested.H6: health effect clinical code: e172003 refers to consumer alleged for "contact dermatitis- large weeping lesions on legs and elbow, swelling and itch".This is 3 of 5 med-watches (bab 03- left leg) being submitted as five devices were involved in this event.See medwatch 8041154-2023-00029; 8041154-2023-00030; 8041154-2023-00032; 8041154-2023-00033.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, an additional 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.H2, 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 december 08, 2022.Raw material and component records were reviewed and were found acceptable.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow- up medwatch will be filed as appropriate.This is 3 of 5 med-watch follow-ups (bab 03- left leg) being submitted as five devices were involved in this event.See medwatch 8041154-2023-00029; 8041154-2023-00030; 8041154-2023-00032; 8041154-2023-00033.The same patient is represented in each medwatch follow-up.
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Search Alerts/Recalls
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