Catalog Number NLD-15597C-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 10/27/2015 |
Event Type
Injury
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Manufacturer Narrative
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The actual sample was not returned for investigation.The supplier of the anaesthesia medication completed a review of manufacturing records for the reported lot and concluded that the product met with specifications at final testing.The supplier also tested retained samples from the same lot for potency.All testing found the product to meet with specifications.
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Event Description
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A report was received that stated that a patient received insufficient local anesthesia when the listed medical device was used.It was necessary to place patient under general anesthesia during the procedure.No adverse effects to patient reported.
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Search Alerts/Recalls
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