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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Molnlycke health care canada is reporting that during an internal investigation molnlycke health care ab detected failures in a sterilization validation for the brennen skin graft mesher. with the current sterilization instructions we cannot assure sterility of the mesher. molnlycke is taking this matter very seriously and is now performing a field safety corrective action (fsca) concerning the identified product codes.