Events

Alerte De Sécurité sur Echelon Reinforced Micro Catheter - Record 80301610021 - Risk Class IV ## Models: 105-5091-150; 145-5091-150; 190-5091-150; 105-5092-150; 5092-150

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 Micro Therapeutics, Inc.; EV3 Comércio de Produtos Endovasculares; AUTO SUTURE 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
    1393
  • Date
    2014-06-16
  • 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 the company, due to the incorporation of EV3 Comércio de Produtos by Auto Suture do Brasil, it will continue with all actions related to this field action, EV3 of Endovascular Products being the holder of this register. ### UPDATED ON 08/18/2017, fieldwork documentations submitted by the company are archived in the area. If necessary, the area can reassess the action at any time.
  • Cause
    "during the update of the nationalization label of the product in question, the registration number (80102510081) of the holder vr medical imp. and dist. prod. medicos ltda. , to 80301610021, registered by ev3 endovascular products trading of brasil ltda. however, this modification contemplated only the registration number and remained with obsolete registration holder information. " the company also reported that it did not identify risk to the patient and reported that the problem does not interfere with the use of the product.
  • Action
    It will be corrected in the Nationalization Tag Update field. ## According to the company (Field Action notification form), the products under risk in Brazil are quantified as follows: Total product under risk in Brazil: 795; Marketed quantity: 466; Quantity in stock: 329.

Device

Echelon Reinforced Micro Catheter - Record 80301610021 - Risk Class IV ## Models: 105-5091-150; 1...

Manufacturer

Micro Therapeutics, Inc.; EV3 Comércio de Produtos Endovasculares; AUTO SUTURE DO BRASIL LTDA
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA