Events

Alerta De Seguridad para BEAD BLOCK MICRO-SPHERE FOR BOILING. Anvisa Registry n ° 80012280078. Models under risk: Bead Block 100-300 micrometers and 300-500 micrometers.

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 Ltda.; Biocompatibles UK LTD.

¿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
    1523
  • Fecha
    2015-03-09
  • 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
    Suppliers and health care facilities using this product should alert product users to incorrect product information on the product label, thus avoiding the possible (incorrect) use of spheres with diameters of less than 500 micrometers in the case of uterine fibrosis. The information in the Instructions for Use is correct as to the indication of use of the product.
  • Causa
    Incorrect product labeling in english stating that product sizes 100-300μm and 300-500μm can be used for uterine fibrosis (when in fact only products of size 500-700μm, 700-900μm and 900- 1200 μm are indicated for uterine fibrosis).
  • Acción
    The company has already started communicating the problem to its suppliers and customers. Users of the product should pay attention to the information contained in the Product Use Instructions, which are correct. See the alert message at: http://portal.anvisa.gov.br/wps/wcm/connect/c5073c0047951ed683cbebfe096a5d32/Community+Access+of+Camp .pdf? MOD = AJPERES

Device

BEAD BLOCK MICRO-SPHERE FOR BOILING. Anvisa Registry n ° 80012280078. Models under risk: Bead Blo...

Manufacturer

Terumo Medical do Brasil Ltda.; Biocompatibles UK LTD
  • Source
    ANVSANVISA