Events

Alerta De Seguridad para Product: Angiographic catheter with hydrophilic surface. Model (s): SCBR4.0-35-150-P-NS-O. Registro Anvisa n °: 10212990249./// On 12/01/2015 - added new lots for the collection: 4350176; 4552616; 4,598534; 4594005; 5,459,289; 4,582479 and 4604577.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por E. TAMUSSINO & CIA. LTDA; COOK INCORPORATED.

¿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
    1751
  • Fecha
    2015-11-21
  • 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
    The recall was initiated by the company because of the potential to cause serious adverse events. Potential adverse events that may occur as a result of division and separation of the catheter tip may include: loss of device function, medical intervention to recover segmented segment and resulting complications from separate tip, such as obstruction of blood flow to the terminal organs.
  • Causa
    The manufacturer, cook medical has received reports of splitting or separation from the catheter tip. potential adverse events that may occur as a result of division and separation of the catheter tip: loss of device function, medical intervention to recover separate segment or resulting complications from separate tip - such as obstruction of blood flow to the terminal organs.
  • Acción
    The products are being collected by the registration holder in Brazil (E. Tamussino & Cia Ltda). Segregate the products at risk and inform the company as soon as possible so that the necessary measures are taken. Company code for the field action: T10071-32.

Device

Product: Angiographic catheter with hydrophilic surface. Model (s): SCBR4.0-35-150-P-NS-O. Regist...

Manufacturer

E. TAMUSSINO & CIA. LTDA; COOK INCORPORATED
  • Source
    ANVSANVISA