Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Cardio Sistemas Comercial e Industrial Ltda..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1371
  • Date
    2014-03-06
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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
  • Cause
    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.