Events

Alerta De Seguridad para Mask for Oxygen Supply KYOLING

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 Hangzhou Jinli Medical Appliances Co., 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
    Safety alert
  • ID del evento
    R1710-500
  • Número del evento
    2017DM-0000761-R1
  • Fecha
    2017-10-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=66
  • 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 importer reports that the diameters of the oxygen dials have a diameter greater than normal, this accessory of the device is difficult to exchange, leading to possible delays in the procedures or adverse events on patients.

Device

Mask for Oxygen Supply KYOLING
  • Modelo / Serial
    HX.O02, lots 32611504, 32611602, 32611607, 32611612
  • Descripción del producto
    This sanitary registry covers the models HX.O01, HXO02, HX.O04 in sizes XXL, XL, L, M, S, XS. Associated labels conradicated no. 2017031444 of March 08, 2017 with updated and additional information. Authorization of labels in the sense of updating in the field of "color of the diluent" the distribution of the colors that is found on the label of the mask for oxygen supply ventury, by means of 2017121480
  • Manufacturer
    Hangzhou Jinli Medical Appliances Co., Ltd

Manufacturer

Hangzhou Jinli Medical Appliances Co., Ltd
  • Source
    NIDFSINVIMA