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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An issue was detected with the seal on the foil pouch which contains the electrodes within the pad-pak/pedi-pak. on a samll number the final seal of the defibrillation electrode pouch was difficult to open. after an investigation it was found that the supplier of the electrodes to heartsine technologies ltd. made a change to the manufacturing process which meant an excessive amount of hot melt glue was applied to the final seal of the pouches.