Events

Alerta De Seguridad para 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 Smith & Nephew 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
    I1410-417
  • Número del evento
    2010DM-0006229
  • Fecha
    2014-10-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=193
  • 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 he has made changes in the instructions for use and in some canister the entrance port may be deformed, leading to the fact that his unknowing may cause possible adverse events to occur on the patients.

Device

Negative Pressure Wound Therapy System
  • Modelo / Serial
    RENASYS EZ, RENASYS EZ PLUS, RENASYS EZ MAX, RENASYS GO, specific lots
  • Descripción del producto
    This device is indicated in patients who may benefit from a suction device (negative pressure) to promote wound healing eliminating fluids (including body and irrigation fluids, wound exudates and infectious materials.) Includes acute, traumatic, sub acute wounds. and by dehiscence, ulcers (such as pressure or diabetics), partial thickness burns, flaps and grafts.
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.