Alerta De Seguridad para Several

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por P.SIMON INDÚSTRIA E COMÉRCIO LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    769
  • Fecha
    2004-05-04
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    considering the provisions of paragraph 3 of art. 111 of the Internal Regulations approved by Administrative Rule no. 593 of August 25, 2000, republished in the Official Gazette of December 22, 2000; considering the provisions in art. 7 of Law no. 6,360, dated September 23, 1976 and art. 1 of Decree no. 79,094, dated January 5, 1977; considering the provisions of item III of art. 2, and subsections XIV and XV of art. 7 of Law no. 9,782, dated January 26, 1999; considering the provisions of RDC no. 59, dated June 27, 2000, which establishes the requirements of Good Manufacturing Practices and Control of Medical Products; considering the CVS Communiqué no. 101/2004 of the Sanitary Surveillance Center of São Paulo, published in the Official Gazette of the State of São Paulo on March 30, 2004
  • Causa
    Failure to comply with good manufacturing practices.
  • Acción
    Prohibition and suspension of the sale of products, subject to registration or registration with ANVISA, including cannulas, collection bags and flasks, connectors, connections, drainage systems and drains. Determine the collection, by the manufacturer company, of the products marketed, presenting VISA / SP, DIR I, the corresponding report.

Device

Manufacturer