Events

Alerte De Sécurité sur Several

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 P.SIMON INDÚSTRIA E COMÉRCIO LTDA.

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
    769
  • Date
    2004-05-04
  • 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
    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
  • Cause
    Failure to comply with good manufacturing practices.
  • Action
    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

Several

Manufacturer

P.SIMON INDÚSTRIA E COMÉRCIO LTDA
  • Source
    ANVSANVISA