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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Manufacturing defect results in that the connection between the proximal 4-holes attachement and the inner tube is too weak to withstand the loads applied during intended use. attachment may break away from inner tube resulting in severe instability and potential causing patient to fall.