Events

Safety Alert for non-adherent dressing to cover wounds Metalline

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Lohmann & Rauscher International Gmbh & Co.Kg..

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
    R1607-306
  • Event Number
    2009DM-0003399
  • Date
    2016-07-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • 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 detected the possible presence of needles or segments of needles on or inside the non-woven layer of some finished products, considered as a contaminated product, leading to possible adverse events on the patients or users.

Device

non-adherent dressing to cover wounds Metalline
  • Model / Serial
    23084, 23093 and 23094, lots 550512208, 603212208, 606412208, 609212208, 614312208, 606512208, 609412208 || and 614512208.
  • Product Description
    Prolonged treatment of patients with eschar by burns with chemicals and abrasions and tissue loss in general injuries in traumatology, surgery, dermatology andphlebology. As a dressing in first aid. Deurgencias rooms, supported by drains and tutors, tracheotomies.
  • Manufacturer
    Lohmann & Rauscher International Gmbh & Co.Kg.

Manufacturer

Lohmann & Rauscher International Gmbh & Co.Kg.