Events

Alerta De Seguridad para Bronchoscope FN-53A, Larynx-Fibro Pediatric FN-40A and flexible endoscopes.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por HUGER ENDOSCOPY INSTRUMENTS CO., LTD; Brazilian Endoscope Industria e Comercio de Equipamentos Medicos Ltda./ENDOBRAX.

¿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
    1278
  • Fecha
    2013-07-02
  • 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 Technovigilance Unit will be monitoring and evaluating the effectiveness of the collection of the products./////// UPDATE - 08/13/2014 - Published Resolution - RE n. 3,047 dated August 12, 2014. DOU n ° 154, of 08/13/2014, considering the contents of the Investigation Report of the Superintendency of Sanitary Surveillance of the State of Minas Gerais, whose findings detected a typo when the Brazilian company Endoscope Indústria e Comércio de Equipamentos Médicos Ltda./ENDOBRAX (CNPJ: 07.427.470 / 0001-85), causing incorrect coding and, therefore, the lack of a registration number in the electronic system of this Agency. The company corrected the typo on its website, as documented in the mentioned report.
  • Causa
    Marketing of health products without registration./////// update - 08/13/2014 - the superintendency of sanitary surveillance of the state of minas gerais issued a research report stating that a typo was identified when developing the electronic site of the company brazilian endoscope indústria e comércio de equipamentos médicos ltda./endobrax, causing incorrect coding and, therefore, the lack of a registration number in the electronic system of this agency. the error has already been fixed.
  • Acción
    To determine, as a measure of health interest, the suspension of the importation, distribution, disclosure, trade and use of the FN-40A Bronchoscope, Fibro Laringo-Bronco Pediatric FN-40A products and flexible endoscopes, as well as collection of the products specified above. // UPDATE - 08/13/2014 - Repeal of Resolution RE No. 2.286, of July 1, 2013. DOU n ° 125, of 07/02/2013., Through Resolution - RE n. 3,047 of August 12, 2014. DOU No. 154, of 08/13/2014.

Device

Bronchoscope FN-53A, Larynx-Fibro Pediatric FN-40A and flexible endoscopes.

Manufacturer

HUGER ENDOSCOPY INSTRUMENTS CO., LTD; Brazilian Endoscope Industria e Comercio de Equipamentos Me...
  • Source
    ANVSANVISA