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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There have been two customer complaints of an unsealed pouch for the included separately packaged sterile inflation assembly and inflation adapter. these components are used together to inflate the ventralight st mesh with echo ps positioning system balloon external to the patient but within the sterile field.