Events

Safety Alert for Non-Invasive Blood Pressure Monitor Dyna-MAPA +, Registration No. 10361050010, Series: see Annex II

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Cardio Sistemas Comercial e Industrial Ltda..

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
    1371
  • Date
    2014-03-06
  • 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
    Informative note is necessary, since patients with allergic or hypersensitive substrate may suffer an allergic reaction. The company advises the users to always keep a good hygiene of the product and check with the patient if they usually have allergic reactions to products and to patients who, in case of problem, call the doctor / laboratory or technical support
  • Reason
    The company holding the registration was informed through the product certification body (brtuv) that the equipment manual does not have information about the possibility of allergic reaction triggered by parts of the product when in contact with the patient. in view of this, the ocp suspended the p-622 certificate of the product until the company realizes the adequacy of the information.
  • Action
    The company that holds the registration in Brazil has made available on the company's website (https://www.cardios.com.br/noticias_detalhes.asp?IdNoticia=501&IdSecao;=11&IdTipoNoticia;=7) the product manual, in electronic format, with Information note about possible allergic reaction triggered by parts of the product when in contact with the patient. This Note will also be forwarded on physical media to users.

Device

Non-Invasive Blood Pressure Monitor Dyna-MAPA +, Registration No. 10361050010, Series: see Annex II

Manufacturer

Cardio Sistemas Comercial e Industrial Ltda.