Events

Safety Alert for PRODUCTS FOR CAUTERIZATION OF COLD WAVES - ALL TYPES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1012
  • Date
    2010-03-26
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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.
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA