Events

Safety Alert for Ultrasonic surgical aspiration system Integra

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Integra Lifesciences Corporation Usa || Integra Radionics Inc. || Integra Neurosciences Pr, Inc. || Integra Neurosciences Ltd. || Integra Lifesciences (Ireland) Ltd..

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
    A1401-31
  • Event Number
    2010EBC-0005704
  • Date
    2014-01-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=211
  • 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
    It was stated by the manufacturer that a lock of the blue button "coag emc" of the equipment can be presented in the "on" position, generating continuous operation, which can lead to potential adverse events on the patient.

Device

Ultrasonic surgical aspiration system Integra

Manufacturer

Integra Lifesciences Corporation Usa || Integra Radionics Inc. || Integra Neurosciences Pr, Inc. ...