Events

Alerta De Seguridad para NC Trek RX Coronary Dilatation Catheter

Según National Drugs Administration from El Salvador (DNM), este evento ( alerta de seguridad ) involucró a un dispositivo médico en El Salvador que fue producido por 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
  • Clase de Riesgo del Evento
    Class I
  • Fecha
    2017-03-22
  • País del evento
    El Salvador
  • Fuente del evento
    DNM
  • URL de la fuente del evento
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notas / Alertas
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • Notas adicionales en la data
  • Causa
    The cause of the alert is due to difficulties in removing the protective cover of the balloon from the catheter, which can lead to problems with inflation and deflation of the balloon. affected lots: 60921g1, 60912g1, 60819g1, 61012g1, 60907g1 the inspection was carried out confirming that 12 units were imported from the affected lots of which only one was commercialized and notified to the health center, the remaining 11 were returned to the manufacturer abbott vascular fedex.
  • Acción
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

NC Trek RX Coronary Dilatation Catheter

Manufacturer

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
    NDAESDNM