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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Smiths medical has become aware of the potential for compression of the inner cannula as a result of handling or certain cleaning methods used outside of the methods described in the ifu. compression can result in a shorter overall length and may lead to a build-up of secretions within the end of the tracheostomy tube with risk of infection or occlusion. smiths medical is therefore advising customers of additional information for safe and effective use of bivona inner cannula.