Events

Safety Alert for Helioseal F Sealant

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

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
    R1512-536
  • Event Number
    2008DM-0001747-R1
  • Date
    2015-12-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=165
  • 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 that the medical device may contain particles larger than the size defined in the formula, which could make it difficult to extrude the sealing material during a procedure, potentially leading to adverse events on patients.

Device

Helioseal F Sealant
  • Model / Serial
    558519AN and 558518AN, with lots U12511 and U19925 respectively
  • Product Description
    For the sealing of cracks, pits and foramina caeca
  • Manufacturer
    Ivoclar Vivadent AG

Manufacturer

Ivoclar Vivadent AG