Events

Alerte De Sécurité sur Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)

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

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
    2012-08-07
  • Date de publication de l'événement
    2012-08-07
  • 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_20120807a.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: vascutek biplex vascular grafts and biplex biovalsalva conduits (stentless and stented) the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a field safety notice (fsn) concerning biplex vascular grafts and biplex biovalsalva conduits (stentless and stented), manufactured by vascutek ltd. vascutek issued a fsn to increase clinician awareness regarding bleeding, experienced by some customers when using biplex vascular grafts and biplex biovalsalva conduits. of total product sales, which includes biplex vascular grafts and biplex biovalsalva conduits (stentless and stented); field events of graft bleeding are recorded as 2.6%. of this 2.6 % total, 80% of reports are from one country, i.E. italy. in these cases, clinicians have experienced bleeding from graft suture holes and/or anastomoses requiring additional intervention e.G. resternotomy. bleeding and re-intervention to correct bleeding has occurred during or shortly after surgery. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2012.

Device

Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Vascutek Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd