Events

Alerta De Seguridad para Surgical Meshes for Hernia Repair

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 Johnson & Johnson International || Johnson & Johnson Medical Gmbh.

¿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
    R1605-224
  • Número del evento
    2011DM-0007247
  • Fecha
    2016-05-26
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • 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 has initiated the withdrawal of the referenced device after an analysis performed at the recurrence / reoperation rates (respectively) after laparoscopic ventral hernia repair using the device, since they were higher than the average rates of the comparable group of meshes between patients within the the records, leading to adverse events on patients.

Device

Surgical Meshes for Hernia Repair
  • Modelo / Serial
    PHYSIOMESH Flexible Composite Mesh - PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, || PHY2030R, PHY2535V, PHY3035R and PHY3050R, all || lots.
  • Descripción del producto
    PHYSIOMESH is indicated in the repair of hernias and other deficiencies of the fascia that require the addition of a reinforcing material or bridge to obtain the desired surgical result.
  • Manufacturer
    Johnson & Johnson International || Johnson & Johnson Medical Gmbh

Manufacturer

Johnson & Johnson International || Johnson & Johnson Medical Gmbh