Events

Alerta De Seguridad para Trade name: SILICONES DE ADICAO AQUASIL. ANVISA registration number: 8019688020. Risk class: I - Low Risk. Model Affected: AQU ASI L EASY M IX PUTW. Lot number affected: 150629

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.; DENTSPLY CAULK.

¿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
    1919
  • Fecha
    2016-05-12
  • 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
    Customers who have purchased the product must preemptively store it and contact Dentsply for free replacement. Phone: (24) 2233-1818 - rnartelle.cortezia@dentsplysirona.com
  • Causa
    The product silicones de adicao aquasil, presented a change in working time and prey of lot 150629. the problem was detected by the manufacturer through investigation of two complaints and the causes are being investigated through capa by the manufacturer. the user, when using the product, will find a change in working time and prey, resulting in an interference with the quality of the molding, leading to dissatisfaction.
  • Acción
    Collection and destruction by the company holding the registration. Code 2. Letter to the clients in annex.

Device

Trade name: SILICONES DE ADICAO AQUASIL. ANVISA registration number: 8019688020. Risk class: I - ...

Manufacturer

Dentsply Indústria e Comércio Ltda.; DENTSPLY CAULK