Events

Safety Alert for DURA GUARD, PERIGUARD, VASCU-GUARD

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

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
    I1408-319
  • Event Number
    2008DM-0001613
  • Date
    2014-08-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=198
  • 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 received two reports of incorrect use of the device during surgical procedures and recalls that the periguard and vascu-guard are not dura mater substitutes, since they are not indicated for this type of use, this practice can lead to potentially serious adverse events. about him patient.

Device

DURA GUARD, PERIGUARD, VASCU-GUARD
  • Model / Serial
    DURA GUARD, PERIGUARD, VASCU-GUARD
  • Product Description
    It is used as a dural substitute for the closure of the mother in neurosurgical interventions
  • Manufacturer
    Synovis Surgical Innovations

Manufacturer

Synovis Surgical Innovations