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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Wrong labels have been applied to the affected lots. the risk associated with this is minimal-if balloon is incorrectly used in the esophagus the balloon is too small to have a sigfnificant impact.