Events

Alerta De Seguridad para PHIL Liquid Embolic System

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 Microvention Europe || Microvention 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
    R1608-359
  • Número del evento
    2015DM-0013279
  • Fecha
    2016-08-23
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=124
  • 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 the possibility of dispersion of unwanted particles (metal) in the composition of the device, causing a discoloration of the embolic fluid, leading to its use may cause possible adverse events on patients.

Device

PHIL Liquid Embolic System
  • Modelo / Serial
    LEN10250, LEN10300 and LEN10350, lots 15062529 - 15102026 - 15102326 - 16040534 - 15052637 - 15092123 || - 16010528 - 1603142 - 15062539 - 15091029 - 16010637.
  • Descripción del producto
    The liquid embolic system (PHIL) is based on an organic solvent, dimethyl sulfoxide (DMSO). The agent is embolicoliquido in a co-polymer soluble in DMSO and insoluble in an aqueous medium. The iodine is linked to the copolymer as the radiopacifier component. The two components of the PHILL are preloaded in a syringe each, ready to use when leaving the package without the need for a preparation pass. The purpose of the PHILL is to be used in the embolization of peripheral lesions and deneurovasculature, including arteriovenous malformations and hypervascular tumors. In the treatment of neurovascular targets, achieve occlusion of blood flow to increase the ease of surgical resection and / or embolized abnormalities without resection. MVLES can be used together with other therapeutic agents and de-embolization, such as occlusion coils and balloons. Additionally, MVLES's viable applications are as an embolization device in cases of hemorrhagic occlusion and vessel sacrifice.
  • Manufacturer
    Microvention Europe || Microvention Inc.

Manufacturer

Microvention Europe || Microvention Inc.
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    NIDFSINVIMA