Events

Alerte De Sécurité sur Arion silicone breast prosthesis, Record nº 80165560006

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Imact Importação e Comércio Ltda; Laboratoires Arion.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1493
  • Date
    2014-12-29
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    The company must take action to collect the product.
  • Cause
    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.
  • Action
    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