Events

Safety Alert for Dura-Guard and Peri-Guard

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter.

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
  • Date
    2014-07-31
  • Event Date Posted
    2014-07-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140731.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter dura-guard and peri-guard medical device manufacturer, baxter, has issued a field safety notice (fsn) concerning dura-guard (product codes: dg0209snbio, dg0404snbio, dg0608snbio, dg0814snbio) and peri-guard (product code: pc0608n). the manufacturer reminds customers of the approved indications for use for dura-guard and peri-guard. this notification is being sent due to two recent reports involving use of the incorrect product during surgery. dura-guard has the approved indication for use as a dura substitute for the closure of dura mater during neurosurgery. peri-guard is intended for repair of pericardial structures and for use as prosthesis for the surgical repair of soft tissue deficiencies, and it is also intended for use as a patch material for intra-cardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing. the manufacturer advises users that only dura-guard is indicated for use as a dura substitute. peri-guard should not be used as it is not indicated for this type of use. users can continue to use the concerned products according to their instructions for use. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 31 july 2014.

Device

Dura-Guard and Peri-Guard
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter Dura-Guard and Peri-Guard
  • Manufacturer
    Baxter

Manufacturer

Baxter