Events

Alerta De Seguridad para Zimmer dermatome 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 Zimmer Surgical 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
    I1607-302
  • Número del evento
    2012DM-0009099
  • Fecha
    2016-07-26
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • 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 it has detected the possibility of deformation of blisters, peeling or discoloration of the surface coating in use, leading to the appearance of possible adverse events on patients.

Device

Zimmer dermatome system
  • Modelo / Serial
    Concerning the handpieces and their plates, references 00-8851-001-00, 00-8851-001-01, 01-8851-001-00, 00-8851- || 201-00, 00-8851-215-00, 00-8851-202-00, 00-8851-203-00 and || 00-8851-204-00.
  • Descripción del producto
    The ZIMMER electric dermatome is an instrument for cutting skin grafts of different thicknesses and widths. The ZIMMER electric dermatome is a surgical-electric instrument used to section skin layers of different thicknesses in order to perform grafts. The thickness can be adjusted from 0 to 0.75 mm in increments of 0.050mm.
  • Manufacturer
    Zimmer Surgical Inc

Manufacturer

Zimmer Surgical Inc
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA