Events

Safety Alert for DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix and DuraGen Suturable Dural Regeneration Matrix

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

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
    2013-04-24
  • Event Date Posted
    2013-04-24
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130424.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: integra duragen dural graft matrix, duragen plus dural regeneration matrix and duragen suturable dural regeneration matrix the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning duragen dural graft matrix, duragen plus dural regeneration matrix and duragen suturable dural regeneration matrix manufactured by integra lifescience corporation. the affected catalogue numbers are id-1101-(i), id-1105-(i), id-1301-(i), id-1305-(i), id-2201-(i), id-2205-i, id-3305-(i), id-4501-(i), dp-1013-i, dp-1022-i, dp-1033-i, dp-1045-i, dp-1057-i, durs2291, durs3391 and durs4591. through an internal quality assurance review of processes, the manufacturer found that the production process may have deviated during the manufacture of specific lots of product. the product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products. integra is recalling the affected products and advises the clinicians to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00352-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 april 2013.

Device

DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix and DuraGen Suturable Dural Re...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Integra DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix and DuraGen Suturable Dural Regeneration Matrix
  • Manufacturer
    Integra LifeScience Corporation

Manufacturer

Integra LifeScience Corporation