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 is a possibility that the central handle holder detaches from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder resulting in the rivets loosening and detaching from the central handle holder ring. there is a remote chance that this issue may cause post-operative infection foreign body granuloma or allergic reactions if the particles fall into the patient's wound or on sterile equipment.