Alerta De Seguridad para VIVANO negative pressure wound therapy 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 Paul Hartmann Ag.

¿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
    R1704-151
  • Número del evento
    2016DM-0014242
  • Fecha
    2017-04-28
  • País del evento
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
  • 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

Device

  • Modelo / Serial
  • Descripción del producto
    The VIVANO negative pressure wound therapy system is designed to facilitate the healing of wounds through the application of sub-atmospheric topical pressure to the wound site according to the mechanism of vacuum treatment in surgical management of suppurative wounds. In addition to the pump, the VIVANOMED foam assemblies and the VIVANOMED foam dressing assemblies are sterile foam assemblies ready for use with at least one polyurethane foam dressing, a transparent polyurethane film dressing and polyurethane self-adhesive, a connection port with hose. of silicone and a polypropylene tray. The VIVANOTEC port is a flexible system for the suction of exudates from wounds during treatment with negative pressure wound therapy and to apply negative pressure on the wound. In conjunction with the VIVANOTEC negative pressure therapy system, foam dressings ensure reliable removal of wound exudate, with negative pressure being equally distributed at the base of the wound. The connector in and VIVANOTEC is used to connect two VIVANOTEC port systems with a VIVANOTEC negative pressure therapy system.
  • Manufacturer

Manufacturer