Events

Alerta De Seguridad para (1) BIO-MEDICUS FEMURAL CANCER WITH ADVANTAGE GUIDES FOR ADULTS AND MEDIUM INCHES, BIO-MEDICUS PERCUTANEOUS FEMALE CANCER KITS: (2) BLOODY, (3) VENOUS. WE. OF THE PRODUCTS (1) 96370-023, 025, 027, 029, (2) 96530-015, 017, 019, 021, (3) 96600-015, 017, 019, 021.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC 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
    9
  • Fecha
    2001-03-14
  • 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
    Possible insertion difficulty of the recommended 0.038 inch guide at the terminal point of the introduction guide.
  • Acción
    THE MANUFACTURER STARTED WITHDRAWAL ON 22 / SEPTEMBER / 2000. RELEVANT ESTABLISHMENTS AND PROFESSIONALS SHOULD CHECK THAT THEY RECEIVED MEDTRONIC NOTIFICATION. YOU SHOULD IDENTIFY, REMOVE FROM THE USE, YOUR INVENTORY AND RETURN THE AFFECTED PRODUCTS AS INDICATED IN THE MANUFACTURER'S LETTER. FOR FURTHER INFORMATION, TELEPHONY TO CHRIS CAMPBELL-LOTH, MEDTRONIC, 00XX1 (763) 514-8547.

Device

(1) BIO-MEDICUS FEMURAL CANCER WITH ADVANTAGE GUIDES FOR ADULTS AND MEDIUM INCHES, BIO-MEDICUS PE...

Manufacturer

MEDTRONIC INC
  • Source
    ANVSANVISA