Events

Safety Alert for sutures and surgical ligatures Corolene

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

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
    R1710-463
  • Event Number
    2010DM-0006201
  • Date
    2017-10-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=71
  • 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 he has managed to find that the resistance values are not in conformity with the referenced lots, leading to possible delays in the procedures or adverse events on the patients.

Device

sutures and surgical ligatures Corolene
  • Model / Serial
    20S30AR, 20S30M, lots 25452, 999790.
  • Product Description
    Used in cardiovascular procedures, vascular surgery, plastic surgery and surgery in general.
  • Manufacturer
    Peters Surgical

Manufacturer

Peters Surgical
  • Manufacturer Parent Company (2017)
    Eurazeo SA
  • Source
    NIDFSINVIMA