Events

Alerta De Seguridad para AB TRONIC MASSAGE APPLIANCE

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Santa Fé Trading Importação e Exportação 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
    748
  • Fecha
    2003-10-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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 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 arts. 6 and 7 of Law 6360 of September 23, 1976; considering items XXIX and XXXI, of Article 10, of Law No. 6.437, of August 20, 1977; considering items VII, VIII, IX, XV, XXIV, XXVI, of Article 7 of Law 9782, of January 26, 1999; considering Resolution RE 1554/02 and Resolution RDC-185/01; considering the decision of fls. 285 of Administrative Proceeding No. 25351.039646 / 2003-89, regarding the Notice of Infringement No. 25/2003-GGTPS / ANVISA, after a defense analysis presented, resolves
  • Causa
    Suspend the importation, sale, advertising and publicity of the product until its regularization with anvisa / ms.
  • Acción
    Determine, as a precaution, as a measure of health interest, throughout the national territory, the cancellation of the Product Registration Exemption Certificate

Device

AB TRONIC MASSAGE APPLIANCE

Manufacturer

Santa Fé Trading Importação e Exportação Ltda
  • Source
    ANVSANVISA