Events

Alerta De Seguridad para DISCHARGE EQUIPMENT DESCARPACK, Registry nº 10330669037, lot: NEMA035, Fab. 09/2012, Val. 08/2017

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Descarpack Descartáveis do Brasil 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
    1359
  • Fecha
    2014-02-17
  • 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
    UPDATE - 02/24/2014 - The company informs that the recall action has begun and that customers and patients who identify the product must contact the company's SAC by telephone (81) 3538-0730 and e- mail sac.ne@descarpack.com.br //////// UPDATE - 07/13/2014 - The company sent the field action completion form. 800 units of the product were collected and incinerated.
  • Causa
    According to the single sample tax report no. 113.245230, issued by the central laboratory of public health professor gonçalo moniz of the health department of the state of bahia, the product dischargeable equipment descarpack, lot nema035, was considered unsatisfactory in the aspect test ( presence of foreign body and the protective cover of the male connection being disconnected).
  • Acción
    Resolution RE No. 493, of February 14, 2014, determined, as a sanitary measure, the suspension of distribution, trade and use, as well as the collection, throughout the national territory, of the product DISCHARGEABLE EQUIPMENT DESCARPACK, lot NEMA035

Device

DISCHARGE EQUIPMENT DESCARPACK, Registry nº 10330669037, lot: NEMA035, Fab. 09/2012, Val. 08/2017

Manufacturer

Descarpack Descartáveis do Brasil Ltda