Events

Alerta De Seguridad para Sheath Introducer Destination Terumo ;. ANVISA registration number: 80012280098. Risk class: IV ,. Affected model (s); code RSR01. Lot (s): RN16; RN26 and RP03.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Terumo Medical do Brasil; Terumo Medical Coorporation.

¿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
    1806
  • Fecha
    2015-12-11
  • 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 manufacturer, although there are no complaints or reports of patient-related incidents, the lack of coating may make it difficult to navigate the device to the intended vasculature.
  • Causa
    The distal end may not contain the 5 cm of coating as described on the label.
  • Acción
    VOLUNTARY COLLECTION AND DESTRUCTION. Field action code: Terumo Destination Terumo Bulletin. Recommendations to users and patients: Discontinue use immediately and quarantine any product in stock available, refer to the batches cited in this action. Distributors should segregate products from the specified batch and do not distribute them from the company statement. Distributors should send an alert to each customer who received the product to inform them of the problem. The company will collect and replace the units.

Device

Sheath Introducer Destination Terumo ;. ANVISA registration number: 80012280098. Risk class: IV ,...

Manufacturer

Terumo Medical do Brasil; Terumo Medical Coorporation