Events

Alerta De Seguridad para LUPINE LOOP WITH ORTHOCORD ANCHOR SYSTEM - Registration 80145900903 - Affected lots: all numbers below 3571653 of the product codes lupine: 201704, 210705, 210707, 210708, 210709, 210710, 210711, 210712, 222980 and 222981.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1114
  • Fecha
    2012-02-15
  • 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
    The problem was identified during internal investigation upon receipt of a customer complaint in the United States. There are no records in the National Notification System - NOTIVISA. Anvisa follows this Field Action.
  • Causa
    The batches identified may have been assembled with a wrong suture configuration.
  • Acción
    To users and professionals, 1) Discontinue use of the product; 2) Identify the affected product in your inventory; 2) Segregate it; 3) Fill out the Return Form. This form should be used to indicate the condition of your inventory of affected products. Fill out the business response form and fax back 1130301187, including a copy of this form with the product being returned.

Device

LUPINE LOOP WITH ORTHOCORD ANCHOR SYSTEM - Registration 80145900903 - Affected lots: all numbers ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.