Events

Alerta De Seguridad para Mucosal Intranasal Atomization Device MAD NASAL

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 Wolfe Tory Medical 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
    R1710-501
  • Número del evento
    2016DM-0014759
  • 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 manufacturer reports that it has detected that some of the referenced devices are not completely atomizing, so that it may impair the effectiveness of the medication with which it is used, leading to possible delays in the procedures, ineffectiveness of the treatment and adverse events on the patients.

Device

Mucosal Intranasal Atomization Device MAD NASAL
  • Modelo / Serial
    MAD300, lot 160422
  • Descripción del producto
    The present sanitary registry covers the following references: MAD100 (WITH 3 ML SYRINGE), MAD100OS (WITH 3ML ORALSYRINGE), MAD110 (WITH 1ML SYRINGE), MAD110OS (WITH 1MLORAL SYRINGE), MAD130 (WITH 1ML SYRINGE AND VIALADAPTER), MAD130OS (WITH 1ML ORAL SYRINGE AND VIALADAPTER), MAD140 (WITH 3ML SYRINGE AND VIAL ADAPTER), MAD140OS (WITH 3ML ORAL SYRINGE AND VIAL ADAPTER), MAD300 (WITHOUT SYRINGE), MAD800 (WITH 3ML SYRINGE), MAD900 (WITHOUT SYRINGE).
  • Manufacturer
    Wolfe Tory Medical Inc

Manufacturer

Wolfe Tory Medical Inc
  • Source
    NIDFSINVIMA