Alerta De Seguridad para All lots of products manufactured and imported

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PROMINI COMÉRCIO INDÚSTRIA IMPORTAÇÃO E EXPORTAÇÃO DE APARELHOS DIAGNÓSTICOS DE CORREÇÃO DE DEFICIÊNCIAS FÍSICAS 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
    669
  • Fecha
    2002-05-13
  • 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
    § 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; Art. 10, items I, IV, XIX and XXIX, of Law No. 6.437, of August 20, 1977; 12, 50 and 51 of Law no. 6,360, dated September 23, 1976, combined with articles 14, 35, 75 and 78 of Decree No. 79.094 of January 5, 1977; Resolution of SES / RJ No. 1780, published in DOE / RJ No. 59, of April 1, 2002, Report of the Inspection carried out by a team of the Health Inspection Coordination / SE / RJ on March 20, 2002. - -------------------------------------------------- --------- ALERT UPDATE -------------------------------------- -------------------- RE-RESOLUTION No. 795, OF MAY 18, 2004. The Director of the Collegiate Board of the National Sanitary Surveillance Agency, in the use of its attribution granted by Administrative Rule no. 149 of the Chief Executive Officer, dated February 20, 2004, 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 Resolution SES 1865, dated August 6, 2002, issued by the State Health Department of the State of Rio de Janeiro, published in the Official Gazette of August 08, 2002, resolves: Art. 1 Determine the disinterest of the company PROMINI COMÉRCIO INDÚSTRIA IMPORT EXPORTATION OF DIAGNOSTICS CORRECTION APPROACHES OF PHYSICAL DEFICIENCIES LTDA, located at Rua Fagundes Varela, nº 456, Ingá, Niterói, Rio de Janeiro / SP; Article 2 This Resolution shall enter into force on the date of its publication
  • Causa
    Failure to comply with good manufacturing practices, as it does not have an operating permit and no registration of its products with anvisa / ms.
  • Acción
    To determine, as a measure of sanitary interest, throughout Brazil, the prohibition, suspension of the sale, manufacture and use of all batches of products manufactured and imported by the company