Events

Alerta De Seguridad para Arion silicone breast prosthesis, Record nº 80165560006

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Imact Importação e Comércio Ltda; Laboratoires Arion.

¿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
    1493
  • Fecha
    2014-12-29
  • 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
    The company must take action to collect the product.
  • Causa
    In the process of maintaining the use of the seal of conformity identification (product certification), during a factory audit, it was verified that the company adopts two methods of sterilization, ethylene oxide and dry heat, only the sterilization method by ethylene oxide is included in the product registration process.
  • Acción
    Publication of Resolution RE No. 4.881, of December 19, 2014, as described below: "Art. 1º To determine, as a measure of sanitary interest, in the whole national territory, the suspension of the importation, distribution, commercialization and implantation of the product MOLECULAR PROSTHETICS OF SILICONE ARION, which includes on the label the information of sterilized by dry heat in registration No. 80165560006, manufactured by Laboratoires Arion, located in France, registered by Imact Importação e Comércio Ltda. (CNPJ: 03.400.037 / 0001-03). Article 2. To determine, as a measure of sanitary interest, throughout the national territory, the suspension of the importation, distribution, commercialization and implantation of the product PROSTHETIC MOLECULAR SILICONE ARION sterilized by ethylene oxide, registration 80165560006, manufactured from 28/4 / 2014 by the company Laboratoires Arion, located in France, registered by Imact Importação e Comércio Ltda. (CNPJ: 03.400.037 / 0001-03). Art. 3 To determine that the company Imact Importação e Comércio Ltda. promote the collection of existing stock in the market for the products described in arts. 1st and 2nd. "

Device

Arion silicone breast prosthesis, Record nº 80165560006

Manufacturer

Imact Importação e Comércio Ltda; Laboratoires Arion
  • Source
    ANVSANVISA