Events

Safety Alert for Wound Dressings

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Covidien || Jiangsu Likang Medical Products Co. Ltd || Covidien Llc..

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
    R1603-115
  • Event Number
    V- 004202-R1
  • Date
    2016-03-18
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=150
  • 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 identified the possibility of a loss of the sterile barrier, compromised in the seal delempaque, leading to potentially adverse events occur on patients.

Device

Wound Dressings
  • Model / Serial
    CURITY, KERLI AND VISTEC, specific lots.
  • Product Description
    Indicated to be used inside the body or in a surgical incision, or applied to organs and internal structures, to control bleeding, absorb fluids, press organs and structures of abrasion, or contamination. They are also used for the protection of wounds (burns, surgical incisions, abrasions, skin grafts and other superficial wounds) absorbed from wounds, cleaning and debridement of wounds.
  • Manufacturer
    Covidien || Jiangsu Likang Medical Products Co. Ltd || Covidien Llc.

Manufacturer

Covidien || Jiangsu Likang Medical Products Co. Ltd || Covidien Llc.
  • Source
    NIDFSINVIMA