Events

Alerta De Seguridad para HEMORROID CIRCULAR CLEANER PROXIMATE - Record 80145901097 - LOTS AFFECTED - VIDE ANNEX: http://portal.anvisa.gov.br/wps/wcm/connect/29ba32804c843d149d0edd93d95c4045/Lotes+Afetados+1171.pdf?MOD=AJPERES

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde 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
    1171
  • Fecha
    2012-08-28
  • 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
    Read the Letter to Customers carefully. Anvisa follows this action. http://en.wikipedia.org/w/index.php/
  • Causa
    Difficulty in firing the device, resulting in incomplete triggering and consequent incomplete stapling.
  • Acción
    (1). Inspect your inventory immediately to verify that you have the affected product, and separate those products. (2). Fill out the Business Response Form and fax to INCLUDE LOCAL CONTACT, within 3 business days, even if you do not have the product affected. We request that you mention Event 7283. If you have any product to be returned, keep a copy of this form in your records. (3). To return the affected product, take a copy of the Business Response Form, place it in the box with your product, and attach the preprinted shipping label. (4). You are requested to share this information with all appropriate personnel in your facility. As with any medical device, adverse reactions or quality problems, occurring in the use of this product, may be reported to the local representative.

Device

HEMORROID CIRCULAR CLEANER PROXIMATE - Record 80145901097 - LOTS AFFECTED - VIDE ANNEX: http://po...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.