Events

Safety Alert for Negative Pressure Wound Therapy System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Smith & Nephew 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
    I1410-417
  • Event Number
    2010DM-0006229
  • Date
    2014-10-24
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=193
  • 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 states that he has made changes in the instructions for use and in some canister the entrance port may be deformed, leading to the fact that his unknowing may cause possible adverse events to occur on the patients.

Device

Negative Pressure Wound Therapy System
  • Model / Serial
    RENASYS EZ, RENASYS EZ PLUS, RENASYS EZ MAX, RENASYS GO, specific lots
  • Product Description
    This device is indicated in patients who may benefit from a suction device (negative pressure) to promote wound healing eliminating fluids (including body and irrigation fluids, wound exudates and infectious materials.) Includes acute, traumatic, sub acute wounds. and by dehiscence, ulcers (such as pressure or diabetics), partial thickness burns, flaps and grafts.
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.