JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE
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Model Number 4901730021906 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rash (2033); Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/04/2022 |
Event Type
Injury
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Event Description
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A 39 year old female consumer reported an event with band aid brand kizu power pad (kpp) regular.On (b)(6) 2022, the consumer injured the inner side under the right wrist, and a cut developed.She applied kpp large to the affected area.On the following day, (b)(6) 2022, redness was slightly noted at the site where the product had been applied, but she replaced the product with kpp regular to go out.On (b)(6) 2022, she removed kpp regular at night because of red rash.On (b)(6) 2022, she visited a dermatologist, who told her that she should apply antebate (betamethasone butyrate propionate) prescribed before to the affected area because of the development of rash.She applied the drug.On (b)(6) 2022, she noticed that a brown mark of the shape of kpp had remained on the skin.The consumer is still experiencing the symptoms.This report is for band aid brand kizu power pad (kpp) regular.See medwatch 2214133-2022-00033 for band aid brand kizu power pad (kpp) large.The same patient is represented in each medwatch.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.This report is for (band aid brand kizu power pad (kpp) regular 10ct ap 4901730021906 4901730021906apb 4901730021906apb).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 381371175338 8137117533usa 8137117533usa).Udi # (b)(4), upc: 4901730021906, lot number: 2741c, expiration date: august-31-2024.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products and therapy dates: drug: prednisone (prednisolone, steroid); unknown therapy dates.Drug: bayaspirin (aspirin); unknown therapy dates.Drug: careload (beraprost sodium controlled-release tablet); unknown therapy dates.Drug: epadel (ethyl icosapentate); unknown therapy dates.Drug: revatio (sildenafil citrate); unknown therapy dates.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 september 23, 2021.(b)(4).This report is for band aid brand kizu power pad (kpp) regular.See medwatch 2214133-2022-00033 for band aid brand kizu power pad (kpp) large.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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