Events

Alerta De Seguridad para Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - Hazard Class: II - MEDICAL RISK - Technical Name: Wire Guide - Affected Models: LW0037; LW0057; LW0077; LW0107; LW0137 - Affected lots: SEE List of affected lots and distribution map (IN ANNEX)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Politec Importação e Comércio Ltda.; Bard Peripheral Vascular, Inc..

¿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
    1420
  • Fecha
    2014-09-09
  • 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 Politec Importação e Comércio Ltda., "It is advisable to closely monitor patients who are known to have been treated using these affected location wires and are still at risk of developing infectious complications. responsible doctor. "
  • Causa
    The bard dualok seal injury wire may inadvertently penetrate / puncture / cut off its original packaging, thus breaking its sterility barrier and bringing the product into contact with the outside of the packaging. the problem described may increase the risk of injury, including complications associated with localized or systemic infections, which may require medical intervention to prevent serious injury.
  • Acción
    Company will make the collection and return it to the manufacturer, located in the United States. Code 170/2014.

Device

Trade name: WIRES FOR LOCATION OF INJURY IN THE BARD DUALOK SEALS - Registration: 10178010188 - H...

Manufacturer

Politec Importação e Comércio Ltda.; Bard Peripheral Vascular, Inc.
  • Source
    ANVSANVISA