Events

Alerta De Seguridad para SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 10237580042. Batch: BE30H / 14D01.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd..

¿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
    1516
  • Fecha
    2014-12-17
  • 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
    At the moment, no technical complaint regarding this model / batch has been registered that could offer any risk to its users. This was a field action triggered based on the information received from COVISA (SP), published in the DOC of 11/27/2014 - page 81. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action proving the destination of non-compliant products.
  • Causa
    Identified the presence of a foreign body (hair) attached to the sealing of the packaging of this needle, resulting from unsatisfactory aspect analysis.
  • Acción
    The company that holds the register will collect the needles. The company advises customers to immediately discontinue the use of the product from the batch mentioned, segregating them and identifying them so that they are not inadvertently used. They will be collected and destroyed. (LETTER TO THE CUSTOMER IN ANNEX)

Device

SOLIDOR HYPODERIC NEEDLE, Hazard Class II, Model: 40 x 1.2 (18G x 1 1/2 "), Registration: 1023758...

Manufacturer

LAMEDID COMERCIAL E SERVIÇOS LTDA; Anhui Easyway Medical Supplies Co., Ltd.
  • Source
    ANVSANVISA