Catalog Number 8882B |
Device Problem
Reaction (1514)
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Patient Problem
Reaction (2414)
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Event Date 01/30/2014 |
Event Type
Injury
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Event Description
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Three nurses between the ages of 25-35 developed skin irritation and were seen by the infection nurse.They were given a cream (name not provided) and different gloves were bought for them.One of the three also went to a clinic, but there is no additional information about treatment.
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Manufacturer Narrative
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Cardinal health is filing this as the importer.The complaint was forwarded to the manufacturing facility for investigation.We are awaiting sample return from the customer.When samples are received they will be forwarded to the manufacturing facility for investigation.A follow up report will be filed when the results of investigation are completed.
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Manufacturer Narrative
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Samples were received and the lot# was provided.The device history record was reviewed and no abnormalities were noted.Historical trending was done.Based on the returned samples, there was no skin irritation with the wearing test.There has been no change in the formulation of the glove.The supplier has been apprised of this reported incident for close monitoring of the manufacturing process.No corrective action will be taken at this time as we are unable to identify the root cause.We will continue to monitor complaints for any trends of this nature.
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Event Description
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The customer has provided additional information since the initial medwatch was submitted.Apparently two of the three nurses did not require "cream" as initially reported.The 3rd nurse apparently started with a rash to both hands on (b)(6) 2013 and used non-medicated body cream.However she had symptoms reoccur in (b)(6) 2013 and was treated at a clinic with solumedrol 125mg im, and prednisone 20mg tabs.She is doing better now.This reaction was initially reported to cardinal health as occurring on 1/30/2014.The additional specifics of the reaction were not reported to cardinal health until 02/28/2014.
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Search Alerts/Recalls
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