Events

Alerta De Seguridad para Trade name: GRAFTYS HBS Technical name: OSSEO ENZYME Registration number ANVISA: 80517190001 Hazard class: III Affected model: GYHBSV1Q5, GYHBSV1Q8, GYHBSV1Q16

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL.

¿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
    2196
  • Fecha
    2017-02-09
  • 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
    If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Causa
    Due publication of resolution re n ° 325 of february 7, 2017, anvisa determined, as a measure of health interest, in all national territory, article 1, suspension of imports, distribution, marketing and use of graftys hbs and graftys products bcp, imported by the company latim american solutions improtação e exportação ltda, cnpj 09.183.319 / 0001-74, considering the conclusion of the unsatisfactory international inspection report for the graftys sarl manufacturing company of these products, whereas most non-conformities found related directly with the products. in article 2 of this same resolution it has been determined that latin american solutions importação e exportação ltda carries the collection of graftys hbs and graftys bcp products in any national territory. the company will make measures for the pickup to be performed and for the compliance of the suspension.
  • Acción
    Field Action Code 01 2017 triggered under the responsibility of the company LAS - LATTIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company will collect.

Device

Trade name: GRAFTYS HBS Technical name: OSSEO ENZYME Registration number ANVISA: 80517190001 Haza...

Manufacturer

LAS LATIM AMERICAN SOLUTIONS IMPORTAÇÃO E EXPORTAÇÃO LTDA; GRAFTYS SARL
  • Source
    ANVSANVISA