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Catalog Number 352894 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Chills (2191); Malaise (2359)
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Event Date 06/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A thorough investigation could not be performed without a sample to evaluate and the exact root cause of the reported incident cannot be determined at this time.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.While we are unable to confirm the specific nature of the reported event, we will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
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Event Description
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As reported by the user facility: patient was scheduled for a procedure and 10 minutes within the start of the iv (0.9% sodium chloride), patient had an allergic reaction consisting of chills, nausea and malaise.The patient's temperature and blood pressure remained in normal range.The patient's iv was discontinued and she was given benadryl.Symptoms subsided after several days.
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Search Alerts/Recalls
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