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.
데이터 추가 비고
원인
Villa sistemi medicali became aware that a patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and the table was moving from vertical position. the analysis showed that the footrest of the device detached from the table top because the safety screws were discarded at installation. the purpose of these screws is to prevent the footrest to completely detach from the table in order to avoid the patient to fall.