A male consumer reported an event with a band aid flexible fabric extra large bandages.Consumer started using flexible fabric large band aid on (b)(6) 2022 for wound care.Consumer alleges that dirt, perspiration and other items got under the bandage and the wound got infected on (b)(6) 2022.Consumer stated that the scab came off when he removed the band-aid, and his wound is still infected and leaking white puss.After he stopped using the band-aid the wound got worse, it got larger, and he has an outline of where the adhesive was.His skin is all broken down where the adhesive was.Consumer¿s wife, who is an icu nurse, cleaned the area and put an unspecified antibiotic ointment and re-bandaged it.Consumer is still not recovered at time of reporting.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 1000599868-2022-00009.The same patient is represented in each medwatch.
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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) bab flexible fabric extra large usa 381370056850, lot/ctrl # 210531.Udi #: (b)(4); upc #: 381370056850; lot #:210531; expiration 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 may 31, 2021.This is 2 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 1000599868-2022-00009.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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