Events

Alerte De Sécurité sur CATEGORIE ANGIOGRÁFICO IMAGER II. Registro Anvisa n ° 10341350453. List of affected lots available at: http://portal.anvisa.gov.br/wps/wcm/connect/bb4441804aaac25d9f86df4600696f00/Alerta_1120_Lista_de_Produtos_Afetados.pdf?MOD=AJPERES

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 Boston Scientific Corporation; Boston Scientific do Brasil 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
    1120
  • Date
    2012-03-26
  • 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
    According to information presented by Boston Scientific, the holes are not detectable by visual inspection of the product. The problem has been investigated by the company and the most likely cause is that there has been physical interaction between the outer carton of the product and its internal packaging during transportation of the product. For other information and access to the Monitoring Form provided by the company, see the Letter of Notification to the client available in: http://portal.anvisa.gov.br/wps/wcm/connect/5b0386004aaabf659f79df4600696f00/Alerta_1120_Carta_de_Notificacao_ao_Cliente.pdf?MOD=AJPERES #### 28/06/2012 - UPDATE - Completion of the field action, resulting in the collection of 1519 units, all exported to Boston Scientific Corporation - Quincy. ####
  • Cause
    Small holes in the package can cause loss of product sterility.
  • Action
    To the user of the product the following actions are recommended: look for in your stocks products affected by this recall and, if you locate them, stop using them immediately. Segregate and identify the affected products to avoid inadvertent use. Fill out and return the Follow-up Form to Boston Scientific do Brasil Ltda, even if you do not have affected products in your stock - email quality@bsci.com and Fax: (11) 5853-2631. After sending the form, wait for company contact for shipping and replacement of products.

Device

CATEGORIE ANGIOGRÁFICO IMAGER II. Registro Anvisa n ° 10341350453. List of affected lots availabl...

Manufacturer

Boston Scientific Corporation; Boston Scientific do Brasil Ltda
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA