Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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This recall is being initiated by cook medical due to reports received indicating the introducing dilator component extends beyond the introducer sheath further than intended and does not conform to the specifications. potential adverse events that may occur as a result of the excess dilator length include difficulty in accessing the hepatic vein requiring additional manipulation which could result in vessel injury.