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
During review of the ifu it was detected additional missing contraindications and reprocessing instructions also required revision. there is no clinical data linked to the usage of the ds clips for the closure of the renal artery or renal vein during nephrectomies in living donor patients aesculap wants to avoid any potential patient risk by including this and other missing contraindications and also revising the cleaning and sterilization instructions.