Events

Alerta De Seguridad para 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).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ADCA – INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1750
  • Fecha
    2015-11-20
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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.
  • Causa
    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.
  • Acción
    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