Events

Alerta De Seguridad para PRODUCTS FOR CAUTERIZATION OF COLD WAVES - ALL TYPES.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por N/A.

¿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
    1012
  • Fecha
    2010-03-26
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    It is important to note that the diagnosis of warts is not so simple. Inappropriate manipulation of certain lesions, mistaken for warts (such as nevus (pints) or malignant tumors), may impair treatment or interfere with prognosis. Therefore, it is fundamental that consumers of this type of product exercise extreme caution when self-applying. Anvisa is monitoring through the Sentinel Network all the events associated with these products.
  • Causa
    Inappropriate use of products that cauterize cold warts can result in second degree burns and inflammatory processes in places close to applications. such events have been the focus of concern of dermatologists, who envisage serious cicratricial consequences, besides the masking of malignant tumors if applied in these lesions.
  • Acción
    The actions recommended to consumers are as follows: 1) Read the instructions for use of the product carefully before using it. 2) When in doubt about whether the injury is a wart or not, seek the guidance of a trained professional. 3) Diabetes patients should not use the product.

Device

PRODUCTS FOR CAUTERIZATION OF COLD WAVES - ALL TYPES.
  • Modelo / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA