Events

Alerta De Seguridad para Coronary angioplasty catheter (9000005) ANVISA registration number: 80146501766 Hazard class: IV Model affected: 1012444-06, 1012444-08, 1012444-12, 1012444-15, 1012445-20, 1012445-06, 1012445-12, 1012445-15, 1012445-20, 1012446-06, 1012446-08, 1012446-12, 1012446-15, 1012446-20, 1012447-06, 1012450- 08, 1012447-12, 1012447-20, 1012447-25, 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451- 20, 1012451-25, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20, 1012454-08, 1012454-12, 1012454-15, 1012454-20, 1012455-08, 1012455-12, 1012455-15, 1012455-20. Serial numbers affected: Annex 1

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil LTDA; Abbott Vascular.

¿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
    2234
  • Fecha
    2017-03-20
  • 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
    • Check the list of affected lots and models; • Immediately stop the use of the devices in those batches; • Review stock, complete, sign and return to Abbott VAscular the Efficacy Check letter; • Return all unused units to Abbott VAscular; • Share this notification with all relevant people in your institution. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Causa
    Batches identified for this field action may have difficulty removing the protective sheath from the balloon, which may result in problems with inflating and deflating the balloon.
  • Acción
    Field Action Code March 22, 2017 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will collect.

Device

Coronary angioplasty catheter (9000005) ANVISA registration number: 80146501766 Hazard class: IV ...

Manufacturer

Abbott Laboratórios do Brasil LTDA; Abbott Vascular
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA