Events

Safety Alert for Desensitizer Nano P - FGM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Dentscare Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1601-4
  • Event Number
    2010DM-0006409
  • Date
    2016-01-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=162
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    NANO-P, lot 100415
  • Product Description
    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