Events

Alerte De Sécurité sur Product: Intracranial Clip for Brain Aneurysm - ADCA Titanium. Model (s): Standard Fenestrado 3,5mm. Anvisa Registry n ° 80116050002. Products under risk: Lot 0265-2015 (manufactured 05/13/2015) and lot 0266-2015 (manufactured 05/05/2015).

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 ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO 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
    1750
  • Date
    2015-11-20
  • 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, the products have been tested and approved by quality control and the technical failure is restricted only to the exchange of labeling information, which may compromise the progress of the implantation surgery of the product. According to the company, there is no additional risk to patients who already have the product implanted.
  • Cause
    The labels of the products under risk were inadvertently changed. product lot 0265-2015 corresponds to the clip mxt 101, whose blade length is 9mm. product lot 0266-2015 corresponds to the mxt100 clip, whose blade length is 6mm.
  • Action
    The products are being collected by the company. Check your inventory and segregate the products of the lots mentioned, identifying them in order to avoid inadvertent use. There are no additional recommendations if the product has been implanted - patients should follow the postoperative guidelines usually made by the neurosurgeon physician. Company code for the field action: * 01/2015.

Device

Product: Intracranial Clip for Brain Aneurysm - ADCA Titanium. Model (s): Standard Fenestrado 3,5...

Manufacturer

ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA
  • Source
    ANVSANVISA