Alerta De Seguridad para Male condoms "H" - registration 80325300002 - Lots: PM1005; PM1305 and PM1705.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por PH ENGENHARIA INDÚSTRIA E COMÉRCIO 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
    1096
  • Fecha
    2011-10-18
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    According to DRC 62 of September 3, 2008, male condoms for natural rubber latex must also meet the requirements for certification of compliance under the Brazilian System for Conformity Assessment (SBAC). #### UPDATE - 07/11/2011 - The affected lots included in this alert have been incinerated, according to Attached Certificate, in accordance with current legislation. The company will undergo a new inspection and testing for Certification. ####
  • Causa
    Failure in the counter-test tests as evidenced by test reports no. 212.151 / 1/2/3/11, in the possession of the certifying body.
  • Acción
    Check for the existence of the affected product in your inventories and segregate them for recall from the manufacturer, record holder.

Manufacturer