Events

Alerte De Sécurité sur L-Gel Ultrasound Transmission Gel

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

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
    2012-08-17
  • Date de publication de l'événement
    2012-08-17
  • 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_20120817.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: shanghai shenfeng l-gel ultrasound transmission gel the australia therapeutic goods administration (tga) has issued a recall of all lots of l-gel ultrasound transmission gel manufactured between june 2011 and may 2012 by shanghai shenfeng, china. the gel is supplied in 250ml and 5l bottles. the recall was initiated after tga tests found bacterial contamination (burkholderia cepacia, stenotrophomonas maltophilia and raoultella planticolla) in lot numbers 2011 06 17 to 2012 04 09 of the product. there is a small risk that patients who have been exposed to contaminated l-gel ultrasound transmission gel may develop an infection, this infection will usually be in the area where the gel was used. stop using l-gel ultrasound transmission gel products with lot numbers 2011 06 17 to 2012 04 09. identify patients who have been exposed to these lots of l-gel ultrasound transmission gel. review the procedures they underwent and the outcomes of the procedures, and take further action as necessary. for details, please refer to tga website: http://www.Tga.Gov.Au/safety/alerts-device-l-gel-120816.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 august 2012.

Device

L-Gel Ultrasound Transmission Gel
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Shanghai Shenfeng L-Gel Ultrasound Transmission Gel
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH