Events

Alerta De Seguridad para Catheter for measurement of tissue oximetry LICOX., Class IV, Model: CC1. P1. Record: 10099430125. Serial number: 260614 (in stock in the company).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DABASONS Importação Exportação e Comércio Ltda.; GMS Gesellschaft für Medizinische Sondentechnik mbH.

¿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
    1520
  • Fecha
    2014-11-11
  • 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 importing company clarified that the product will be collected and forwarded to the manufacturer. There was no report of patient harm or adverse health effects associated with this complaint. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Causa
    The company integra lifesciences has identified that there is a possibility that the pbto² readings may be underestimated due to an improperly programmed smart card when using one of the catheters.
  • Acción
    The company holding the record explained that of the affected products, it had imported only one lot, all were still in the company's stock and, so far, we had not marketed any units. Fifteen units were imported and they were segregated and later returned to the manufacturer.

Device

Catheter for measurement of tissue oximetry LICOX., Class IV, Model: CC1. P1. Record: 10099430125...

Manufacturer

DABASONS Importação Exportação e Comércio Ltda.; GMS Gesellschaft für Medizinische Sondentechnik...
  • Source
    ANVSANVISA