Events

Alerta De Seguridad para Glove for Non-Surgical Procedures Model Sempermed Phoenix, brand Sempermed (latex, smooth, ambidextrous, non-sterile, with powder, sizes P and PP). Anvisa Registry: 10307890003.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por SEMPERMED BRASIL COM. EXTERIOR 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
    1008
  • Fecha
    2010-03-10
  • 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
    According to information received by Anvisa, the suspension occurred due to non-compliance observed in the item 'thickness' during the analysis carried out by Instituto Falcão Bauer da Qualidade laboratory. According to RDC 05, dated February 15, 2008, the certification of gloves is a prerequisite for its commercialization. #### Update (03/15/2010): Anvisa's RE 1000/2010 suspends import, distribution, trade and use of the product cited in this alert.
  • Causa
    Suspension of the authorization for the use of a seal of identification of conformity, by the product certification body (instituto falcão bauer da qualidade).
  • Acción
    ---

Device

Glove for Non-Surgical Procedures Model Sempermed Phoenix, brand Sempermed (latex, smooth, ambide...

Manufacturer

SEMPERMED BRASIL COM. EXTERIOR LTDA
  • Source
    ANVSANVISA