Events

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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Cardio Sistemas Comercial e Industrial Ltda..

¿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
    1371
  • Fecha
    2014-03-06
  • 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
    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
  • Causa
    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.
  • Acción
    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.