Events

Alerta De Seguridad para USP 0.25 mg / ml. injection of Digoxin in 1 ml of Tubex cartridges; (2) USP 50 mg / ml. injection of Dimenhydrin in 1 ml. of cartridges Tubex; (3) USP 50 mg / ml. of Difenidramine HCI injection in 1 ml. of Tubex cartridges .. Lots Nos .: (1) 4990194, (2) 49990197, (3) 49990052

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Wyeth-Ayerst Laboratories.

¿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
    231
  • Fecha
    2000-12-15
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The tubex cartridges mentioned may be torn or torn. the plant initiated a removal by letter dated july 17, 2000. the firm did not provide any information to ecri on the subject.
  • Acción
    Make sure you have received the July 17, 2000 letter from Wyeth-Alerst Laboratories. Identify and isolate any damaged product from your inventory. For more information, contact your local representative or directly with Wyeth-Ayerst Laboratories product quality department at 1 (610) 902-1200 in the USA.

Device

USP 0.25 mg / ml. injection of Digoxin in 1 ml of Tubex cartridges; (2) USP 50 mg / ml. injection...

Manufacturer

Wyeth-Ayerst Laboratories
  • Source
    ANVSANVISA