JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KIZU POWER PAD; DRESSING, WOUND, OCCLUSIVE
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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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 unspecified ap not applicable rgebabkapa).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).Udi# is not available.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).There are 4 med-watches being submitted as similar events were reported based on initial reporter's event.The same symptoms were represented in each medwatch.2214133-2021-00008 represents the case for a consumer who came to the reporter¿s hospital after applying kpp to a burn wound twice, 2214133-2021-00007 represents the case of an adult female with same issues; this report represents the case of the (b)(6)-year-old girl with same issues; and 2214133-2021-00010 was created to represent the reporter¿s report that he/she had previously seen other patients (in addition to the noted 3) who had the similar symptoms.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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Event Description
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Dermatologist reported that many patients (consumers) who applied kpp to burn wounds came to his/her clinic recently.According to the reporter, the consumers seemed not to have understood severity of their burn wounds and felt pain when removing kpp.Also, product was not effective and made the wound worse.Consumer was admitted to hospital.There are 4 med-watches being submitted as similar events were reported based on initial reporter's event.The same symptoms were represented in each medwatch.2214133-2021-00008 represents the case for a consumer who came to the reporter¿s hospital after applying kpp to a burn wound twice, 2214133-2021-00007 represents the case of an adult female with same issues; this report represents the case of the (b)(6)-year-old girl with same issues; and 2214133-2021-00010 was created to represent the reporter¿s report that he/she had previously seen other patients (in addition to the noted 3) who had the similar symptoms.
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Search Alerts/Recalls
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