Catalog Number 114748M |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
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Event Date 11/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that 10 minutes after starting treatment with a revaclear 300, the patient lost consciousness and their blood pressure decreased to 83/50 mmhg.The patient received oxygen and dexamethasone 5mg was administered.The blood was returned.Consciousness returned and the patient ¿gradually returned to normal condition¿.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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