Events

Safety Alert for VIVANO 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 Paul Hartmann 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
    R1704-151
  • Event Number
    2016DM-0014242
  • Date
    2017-04-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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

Device

VIVANO negative pressure wound therapy system
  • Model / Serial
  • Product Description
    The VIVANO negative pressure wound therapy system is designed to facilitate the healing of wounds through the application of sub-atmospheric topical pressure to the wound site according to the mechanism of vacuum treatment in surgical management of suppurative wounds. In addition to the pump, the VIVANOMED foam assemblies and the VIVANOMED foam dressing assemblies are sterile foam assemblies ready for use with at least one polyurethane foam dressing, a transparent polyurethane film dressing and polyurethane self-adhesive, a connection port with hose. of silicone and a polypropylene tray. The VIVANOTEC port is a flexible system for the suction of exudates from wounds during treatment with negative pressure wound therapy and to apply negative pressure on the wound. In conjunction with the VIVANOTEC negative pressure therapy system, foam dressings ensure reliable removal of wound exudate, with negative pressure being equally distributed at the base of the wound. The connector in and VIVANOTEC is used to connect two VIVANOTEC port systems with a VIVANOTEC negative pressure therapy system.
  • Manufacturer
    Paul Hartmann Ag

Manufacturer

Paul Hartmann Ag