Events

Alerta De Seguridad para VITAL GOLD SCALP DISPOSABLE WITH SAFETY DEVICE, size 19G, registration 10296900048, hazard class II, lot 140415.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Joãomed Comércio de Materiais Cirúrgicos Ltda.; Tianjin Hanaco Xingda Medical Product Co.

¿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
    1824
  • Fecha
    2016-01-11
  • 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
    The analysis was carried out by the Instituto Adolfo Lutz (IAL) and did not verify inviolability of the packaging and there was no characterization of the foreign body. Nonconformity occurred in a single unit. IAL was asked to sample the product or images for evaluation by the company.
  • Causa
    Precautionary interdiction of the lot described by covisa-sp as a result of the presence of a foreign body in the inviolate packaging of the material.
  • Acción
    The company requests the collection of the quantity in stock in the customers and segregation of the target products of the field action until new measures are taken. Send the company the quantitative data raised.

Device

VITAL GOLD SCALP DISPOSABLE WITH SAFETY DEVICE, size 19G, registration 10296900048, hazard class ...

Manufacturer

Joãomed Comércio de Materiais Cirúrgicos Ltda.; Tianjin Hanaco Xingda Medical Product Co
  • Source
    ANVSANVISA