JOHNSON & JOHNSON CONSUMER INC BAND AID BRAND KIZU POWER PAD AP; DRESSING, WOUND, OCCLUSIVE
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Model Number 4901730077002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); No Code Available (3191)
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Event Date 08/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient identifier, age at time of event, weight and ethnicity and race were not provided for reporting.This report is for (band aid brand kizu power pad large 12ct ap 4901730077002 0037131787apa 0037131787apa).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).Lot # is not available.Udi: (b)(4); lot number: ni; exp date: ni.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).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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One week prior to the day of this reporting, a male consumer got a scratch.He consulted with a pharmacist and was recommended kpp.The affected area swelled white after he started using kpp on (b)(6) 2019, but the skin of the area had not regenerated yet.He had used 5 strips of kpp at the time of this reporting.He stated that a discharge of pus and bleeding occurred on the affected area after he replaced the kpp with a new one.He consulted with a physician, who prescribed terra-cortril.As of this reporting, he was applying terra-cortril to the affected area twice a day.The outcome of the event was unknown.This is one of five medwatches being submitted as five devices were involved in this event.See medwatch 2214133-2019-00108 (band-aid 01), 2214133-2019-00109 (band-aid 02), (band-aid 03), 2214133-2019-00111 (band-aid 04) and 2214133-2019-00112 (band-aid 05).The same patient is represented in each medwatch.
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Search Alerts/Recalls
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