French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
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On 16/04/2010, Afssaps sent the attached message (19/04/2010) (52 ko) to all the healthcare establishments concerning the recall of two lots of Rolko brand stems, due to risk of rupture. These brackets have been marketed as bed accessories from different manufacturers. The competent European authorities have been informed of this measure by Afssaps. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for distribution to the user services and those responsible for the maintenance of the medical beds.