Events

Alerta De Seguridad para MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B15B6, 11B23B7, 11C09BA and 11C16B9.

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

¿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
    1101
  • Fecha
    2011-11-25
  • 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
    Boston Scientific became aware, through customer complaints, that the 0.035 "internal diameter dilator (ID) may have been mislabeled as a 0.038" dilator. According to the company, injuries are not expected to occur as a result of this incorrect labeling, as it would not be possible to advance the dilator through the guidewire. Due to the exchange of labeling, there may be a delay in the procedure during the exchange of devices by the surgeon. #### UPDATE - 02/24/2012 - The company forwards the final report of the field action, declaring the total collection of the affected and forwarded products to the manufacturer. ####
  • Causa
    Incorrect labeling of product dilator - 0.0035 "internal diameter dilator labeled 0.0038".
  • Acción
    The product registration holder has already started collecting the product. Health facilities should remove all affected products from their stocks, segregate them in a safe place and identify them properly so that they are not inadvertently used. The affected products will be collected by Boston Scientific do Brasil Ltda or its distributors.

Device

MEDITATION SHOULDER. Anvisa Registry No. 10341350592. Affected lots: 11B15B6, 11B23B7, 11C09BA an...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA