Events

Safety Alert for Manual Gum Brush and Various

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Shumei Industrial (Shenzhen) Co., Ltd. (Tercero Que Fabrica El Producto) || Sunstar Americas Inc.

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
    R1801-42
  • Event Number
    2007DM-0001084 ; 2007DM-0001085 ; 2007DM-0001083 ; 2010DM-0006218 ; 2015DM-0012709 ; 2015DM-0012822
  • Date
    2018-01-19
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=59
  • 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
    Invima informs that through ivc's visit it was possible to prove that the referenced product was commercialized without complying with the full requirements required by the technical and legal provisions that regulate it, being marketed without lot number, for which the product withdrawal was requested. market in a preventive manner, because it is considered a fraudulent product.

Device

Manual Gum Brush and Various

Manufacturer

Shumei Industrial (Shenzhen) Co., Ltd. (Tercero Que Fabrica El Producto) || Sunstar Americas Inc
  • Source
    NIDFSINVIMA