Events

Alerte De Sécurité sur COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719 and HA140448; COSEAL 4ml: HA130322, HA130637, HA130721 and HA130919.

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 BAXTER HOSPITALAR 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
    1409
  • Date
    2014-08-11
  • 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
    The product may exhibit reduced effectiveness due to failure to form the hydrogel, or even a hydrogel with mechanical resistance. If the product fails to form hydrogel or the hydrogel formed has an inappropriate (mechanical resistance) during a surgical procedure, the surgeon should use a new product kit or adopt an alternative surgical method. Additional information at http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Message+of+Alerta_VENDA.pdf?MOD=AJPERES #### UPDATED ON 08/18/2017, the documentations of the action field sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    The effectiveness of the product may be compromised, given that tests carried out by the company have detected results below the specifications regarding the validity of the product.
  • Action
    BAXTER HOSPITALAR LTDA is collecting the product (affected batches described above). Do not use the product at risk and identify the hazardous units in your stock, segregate them and contact BAXTER or distributor for return purposes. For details on how to proceed, check additional information in the Alert Message posted by the company: http://portal.anvisa.gov.br/wps/wcm/connect/29102a80451087f1936fb7c2afb947e8/Messagem+de+Alerta_VENDA.pdf?MOD=AJPERES

Device

COSEAL 2ml and COSEAL 4ml. Registration Anvisa 80145240375. Lots under risk: COSEAL 2ml: HA130719...

Manufacturer

BAXTER HOSPITALAR LTDA.