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
Erythema (1840); Itching Sensation (1943)
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Event Date 02/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient identifier, gender, weight, and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad (kpp) regular 10ct ap 4901730021906, 4901730021906apb ,and 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 ,and 8137117533usa).Udi #: (b)(4).Upc: 4901730021906.Lot number: 0771c.Exp date: na.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 have been requested.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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An event was reported for band aid brand kizu power pad (kpp) regular.On (b)(6)2022, a reporter¿s spouse (consumer) applied kpp to a cut on the middle finger of the right hand for the first time.On the following day ((b)(6)-2022), the consumer removed the kpp as if to remove an adhesive bandage.Redness like a burn and itching occurred.The consumer thought that the symptoms would resolve themselves without further treatment.Therefore, the consumer discontinued applying kpp and no treatment was given.After that, no sign of healing was noted.On (b)(6)2022, the consumer discontinued use of product, visited a dermatologist, and medicine was prescribed and applied to the affected area daily.As of this reporting, the cut healed, but redness like a burn and itching persisted.
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Manufacturer Narrative
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Johnson & amp; 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 & amp; 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 & amp; johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & amp; johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Corrected data: d4: udi.Upc: 4901730021906.Expiration date: 02/29/2024.Lot number: 0771c.Udi: (b)(4).H4, h6: 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 march 2, 2021.If information is obtained that was not available for the follow-up med watch, an additional follow-up med watch will be filed as appropriate.
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