Events

Alerte De Sécurité sur Dura-Guard and Peri-Guard

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxter.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-07-31
  • Date de publication de l'événement
    2014-07-31
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140731.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Dura-Guard and Peri-Guard
  • Manufacturer
    Baxter

Manufacturer

Baxter