Events

Retiro De Equipo O Alerta De Seguridad para Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS

Según Central Drugs Standard Control Organization, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en India que fue producido por Abbott Healthcare Pvt. Ltd..

¿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
    Recall / Safety Alert
  • ID del evento
    31-307-MD/2017-DC (Re. Reg. 03)
  • Fecha
    2017-04-07
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 recall data from the U.S. and India.
  • Notas adicionales en la data
  • Causa
    Based on the three years clinical data analysis from absorb ii it has been observed that there is an over elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis.
  • Acción
    The Indian agent M/s Abbott Healthcare Pvt. Ltd., has informed this office that the manufacturer has initiated a Field Safety Notice in European countries to communicate that product use will' be limited to established post-market registries to facilitate the collection of real-world evidence for Absorb BVSand Absorb GTl BVSsystems.

Device

Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS

Manufacturer

Abbott Healthcare Pvt. Ltd.
  • 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
    CDSCO