JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KPP (KIZU POWER PAD) BANDAGES; DRESSING, WOUND, OCCLUSIVE
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Model Number 4901730080156 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Itching Sensation (1943); Skin Disorders (4543); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/18/2022 |
Event Type
Injury
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Event Description
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A consumer reported an event with band aid brand kpp (kizu power pad) bandage.Twenty years prior to this reporting, hemiplegia developed.Since (b)(6) 2021, the consumer had been using kpp for bedsore on doctor's recommendation.The consumer felt that the bedsore was getting better with the product while replacing it.On (b)(6)2022, the consumer scratched there, and the affected area became messy.The consumer stated, ¿did not know how to use the product¿.The consumer¿s doctor and nurse treated the affected area on each way and gave the consumer different advises about how to use the product.
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient identifier, age at time of event, gender, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kkp jumbo 3ct ap 4901730080156 4901730080156apa 4901730080156apa).Device is not distributed in the united states, but is similar to device marketed in the usa ((b)(6) 1ct usa 381371175338 8137117533usa 8137117533usa).Udi #: (b)(4).Upc: 4901730080156.Lot number: ni; exp date: na.Device is not expected to be returned for manufacturer review/investigation.This report is for (band aid brand kkp jumbo 3ct ap 4901730080156, 4901730080156apa, 4901730080156apa).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).(b)(4).Affected area was messy.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.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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