Events

Alerta De Seguridad para Curatec adhesive film

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 Lm Farma Industria E Comercio Ltda.

¿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
    R1612-579
  • Número del evento
    2014DM-0012173
  • Fecha
    2016-12-15
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=109
  • 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 there is a presence of fragments of metal in the rayon, due to the breakage of the needle during the process of tissue externalization, leading to possible adverse events being presented to patients.

Device

Curatec adhesive film
  • Modelo / Serial
    Lot 16042803
  • Descripción del producto
    CURATEC FILME SIMEX is an adhesive film designed to fix the primary dressing, such as gauze or foam, and serves as a base for fixing the drainage during the assembly of the therapy system by negative pressure. Promotes the sealing of the medium to help in the formation of vacuum during closure.
  • Manufacturer
    Lm Farma Industria E Comercio Ltda

Manufacturer

Lm Farma Industria E Comercio Ltda
  • Empresa matriz del fabricante (2017)
    Urgo Group
  • Source
    NIDFSINVIMA