Events

Alerta De Seguridad para DYCAL ADVANCED FORMULA II, Registration - 10186370113, Lot 886754F

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

¿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
    1597
  • Fecha
    2015-04-14
  • 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 informs that the hardening of the base paste of the product in question does not pose a risk to the population, since it does not give the product new characteristics that are harmful to health, but prevents its use.
  • Causa
    The product presented a change in the consistency in the base paste of lot 88674f, which consists of hardening of the product, preventing dispensing, making it difficult to use the product.
  • Acción
    The company advises customers who have purchased the product to preventively store it and get in touch with Dentsply for the replacement.

Device

DYCAL ADVANCED FORMULA II, Registration - 10186370113, Lot 886754F

Manufacturer

Dentsply Indústria e Comércio Ltda.