Events

Alerta De Seguridad para Brachytherapy Systems

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Nucleotron Corporation || Mallinckrodt Medical B.V || Qsa Global Inc.

¿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
    I1512-595
  • Número del evento
    2009EBC-0003715
  • Fecha
    2015-12-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=163
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer states that it has detected that when using the option of overlapping tumor fraction in planning with vmat, the system includes a surrounding organ in the destination volume, resulting in an overdose of radiation, leading to potentially adverse events occurring on the patient.

Device

Brachytherapy Systems
  • Modelo / Serial
    Oncentra External Beam, concerning the VMAT module with software version 3.3
  • Descripción del producto
    Indicated for an operator to apply, by remote control, a radioactive source in the body by interstitial, intracavitary, intraluminal, bronchial, endovascular, intraoperative applicator, radiation therapy for the treatment of cancer. Applicators and transfer tubes, an integral part of the system The brachytherapy is used to apply the radiation directly to the patient in the specific sites selected by the doctor and they are the only part of the system that has contact with the patient.
  • Manufacturer
    Nucleotron Corporation || Mallinckrodt Medical B.V || Qsa Global Inc

Manufacturer

Nucleotron Corporation || Mallinckrodt Medical B.V || Qsa Global Inc
  • Source
    NIDFSINVIMA