Events

Alerta De Seguridad para Sistema obtryx Transobturator medio-uretral - registered in Anvisa under nº 10341350393

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
    865
  • Fecha
    2007-04-24
  • 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
    UTVIG awaits return of request of other information, sent to the company.
  • Causa
    Boston scientific do brasil ltda sent a letter to the customers of the referred product, because "it identified that some batches were incorrectly formatted using the model aa / mm (year / month) instead of the format mm / aa (month / year). the "expiration date / product validity" information for the hourglass symbol is correct. however, if the secondary code is scanned, the expiration date information in and directly under the bar code will appear after the current expiration date and will not be in accordance with the information that appears in the "expiration date / ".".
  • Acción
    The Company Boston Scientific do Brasil Ltda. has sent a letter to all customers who have received the affected products guiding it is an Important Notice of Medical Product and not a voluntary withdrawal from the product market; this product does not need to be returned to Boston Scientific do Brasil Ltda.

Device

Sistema obtryx Transobturator medio-uretral - registered in Anvisa under nº 10341350393

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA