Events

Alerta De Seguridad para Trade Name: Endokit /// Record Number: 80689090090 /// Hazard Class: III (High Risk) /// Models Affected: REK24N / REK26N /// Lots Affected: NGYIX401; NGYIX402; NGZG1732

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Bard Brasil Indústria e Comércio de Produtos Medicos 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
    1998
  • Fecha
    2016-09-12
  • 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
    Update of the field action: UPDATED ON 08/30/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Causa
    The instructions for use of the endokit product have errors in the indication of use. the instructions for use say that the product is also indicated for use in the bile duct, however, the product is indicated only to be used for the percutaneous or endoscopic treatment of ureteral and renal stenoses.
  • Acción
    Field Action triggered under the responsibility of the company Bard Brasil Indústria e Comércio de Produtos Medicos Ltda.

Device

Trade Name: Endokit /// Record Number: 80689090090 /// Hazard Class: III (High Risk) /// Models A...

Manufacturer

Bard Brasil Indústria e Comércio de Produtos Medicos Ltda.