Events

Alerta De Seguridad para (IAB) ARROW - FIBEROPTIX ## ANVISA Record Number: 80004970002 ## Hazard Class: III ## IAB-05830-LWS / IAB-05840- LWS ## Models / Batch (s) Affected: IAB-05840-LWS / LOT: 18F14H0060 - IAB-05830-LWS / LOT: 18F14H003

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ISOMEDICAL COMERCIAL; ARROW INTERNATIONAL 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
    1848
  • Fecha
    2016-03-30
  • 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 company points out that the affected products are segregated in their stock and there is no risk of use by users. The two commercialized units were used by a single hospital, during training to incorporate said technology by the service. At the time, no problem was identified.
  • Causa
    Bleeding with significant blood loss during the procedure if there is separation between the valve and the body of the product sheath during use.
  • Acción
    The company is performing the collection of the affected products for later return to the foreign manufacturer. Field Action Code: 002/2016

Device

(IAB) ARROW - FIBEROPTIX ## ANVISA Record Number: 80004970002 ## Hazard Class: III ## IAB-05830-L...

Manufacturer

ISOMEDICAL COMERCIAL; ARROW INTERNATIONAL INC.
  • Source
    ANVSANVISA