Events

Alerta De Seguridad para Harvest Graft Applicator. Anvisa Registry No. 80012280129. Affected lots: GDP-10-0046, GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053 , GDP-10-0054, GDP-10-0055, GDP-10i-0010.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Harvest Technologies Corp..

¿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
    1294
  • Fecha
    2013-09-24
  • 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 submitted by Terumo, a risk assessment was conducted and, based on this investigation, the management of Harvest Technologies Corp. (manufacturer) concluded that the following batches of GDP-10 were affected and should be collected: GDP-10-0046 , GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP -101-0010. Of these lots, only lot GDP-10-0048 was distributed in Brazil.
  • Causa
    The device's luer connector may be broken and may cause leakage of biological material during the procedure.
  • Acción
    Products at risk identified should be segregated and returned to Terumo Medical of Brazil. Additional information should be checked at: http://portal.anvisa.gov.br/wps/wcm/connect/610aec80413743c384a68fa8d08ea2d4/Carta_ao_Cliente.pdf?MOD=AJPERES

Device

Harvest Graft Applicator. Anvisa Registry No. 80012280129. Affected lots: GDP-10-0046, GDP-10-004...

Manufacturer

Harvest Technologies Corp.