Alerta De Seguridad para SLEEVE FOR NON-SURGICAL PROCEDURE NUGARD - Registered at Anvisa under number 80273450001 - Lots affected: see attachment at http://portal.anvisa.gov.br/wps/wcm/connect/8b58fc0048dba2988d489d466b74119d/Alerta_1095_Lotes_afetados.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 OLIMED MATERIAL HOSPITALAR 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
    1095
  • Fecha
    2011-09-29
  • 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 RDC 05, of February 15, 2008, the certification of gloves is a prerequisite for its commercialization. INMETRO, through its Ordinance 233/2008, establishes the directives for such certification. #### 10/28/2011: UPDATE - The Product Certification Body - IFBQ, clarified that not all lots of gloves of the model failed are subject to collection, with only those listed in the Annex remaining. #### 05/12/2011: UPDATE - The Product Certification Body - Instituto Falcão Bauer da Qualidade (IFBQ) - informed the UTVIG that it revoked the suspension of the authorization for use of the seal of conformity identification for the target product of this alert (GLOVE FOR NIR SURGICAL PROCEDURE). The company has collected and destroyed the nonconforming products collected, according to documentation submitted by IFBQ and the company to UTVIG. Alert ended.
  • Causa
    Failure in the annual maintenance tests, in the original traction attribute.
  • Acción
    All the products mentioned herein must be identified and segregated by professionals and services and maintained contact with the registry holder for collection and subsequent destruction.

Manufacturer