Events

Alerta De Seguridad para Generators of Electrosurgery CONMED

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 Conmed Corporation || Conmed Electrosurgery || Conmed Corporation || Consolidated Medical Equipment Company.

¿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
    R1705-154
  • Número del evento
    2013EBC-0010649
  • Fecha
    2017-05-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 the referenced devices are sold with an accessory package (esu), which contains two sterile hand pieces, p / n 7-796-19, it was determined that in the period understood between december 2, 2015 and january 3, 2017 , the accessories were packaged by the manufacturer in non-sterile bags that were labeled as "sterile", leading to possibly being contaminated by the use of non-sterile material and potentially presenting adverse events on the patients.

Device

Generators of Electrosurgery CONMED

Manufacturer

Conmed Corporation || Conmed Electrosurgery || Conmed Corporation || Consolidated Medical Equipme...
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    NIDFSINVIMA