Events

Alerta De Seguridad para Desensitizer Nano P - FGM

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Dentscare 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
    R1601-4
  • Número del evento
    2010DM-0006409
  • Fecha
    2016-01-04
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=162
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected in the referenced medical device, changes in the ph content that can cause irritation in the soft tissues of the mouth, leading to potential adverse events in patients.

Device

Desensitizer Nano P - FGM
  • Modelo / Serial
    NANO-P, lot 100415
  • Descripción del producto
    Indicated to desensitize and / or remineralize the dental surface in the treatment of dental hypersensitivity, dental hypersensitivity treatment associated with prophylaxis, scraping and corono-radicular smoothing, prevention of carious lesion in high-risk patients, active young caries adults, orthodontic patients , elderly patients, patients with special needs, pregnant women, patients with xerostomia, auxiliary in the prevention of erosion in patients who make great ingestion of food and acid drinks and who make current use of drugs, help in the prevention of deerosion in patients committed by vomiting, regurgitation of juice gastric and recurrent gastric refluxes, remineralization of white spot lesions in general.
  • Manufacturer
    Dentscare Ltda

Manufacturer

Dentscare Ltda