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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Terumo cvs initially received nine reports of malfunction of the abd module or the occluder module for the terumo advanced perfusion system 1. its investigation found a faulty component on the modules application board had caused the failures. terumo cvs replaced all modules in the affected population. terumo cvs has subsequently received two additional reports of similar malfunctions. the ensuing investigation concluded that though highly unlikely it is possible for the same component to fail in any module.