JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE
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Model Number 4901730021913 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Scar Tissue (2060)
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Event Date 04/18/2022 |
Event Type
Injury
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Event Description
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A female consumer reported an event regarding band aid brand kpp (kizu power pad) bandages.On (b)(6) 2022, a female consumer applied kpp to a right shin injury.On (b)(6) 2022, pain developed, and redness was noted around the wound.Therefore, she replaced the product with new one.On (b)(6) 2022, she visited the hospital.When the product was removed, a doctor of the hospital told the consumer that cellulitis had developed.Sofuratulle (fradiomycin sulfate) was applied to the affected area for treatment.On (b)(6) 2022, she received an antibiotic drip at the hospital because pain did not subside.On (b)(6) 2022, she received an antibiotic drip again.As of this reporting, the symptom subsided, but a scar remained on the skin.Although she had been using the product for many years, no events had occurred previously.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00024.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 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 identifier, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad (kpp) large 6ct ap (b)(4)).Device is not distributed in the united states, but is similar to device marketed in the usa (band aid brand hydroseal bandages all purpose 1ct usa (b)(4)).Udi #: (b)(4), upc: (b)(4), lot number: 2858c.Expiration date: 09/30/2021 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 october 10, 2018.Causality assessed as not related as cellulitis is bacterial infection and scar was formed as due to cellulitis.This is 1 of 2 med-watches being submitted as two devices were involved in this event.See medwatch 2214133-2022-00024.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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Search Alerts/Recalls
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